Interventional endoscopic ultrasonography: an overview of safety and complications.

Surg Endosc (2014) 28:712–734 DOI 10.1007/s00464-013-3260-5

and Other Interventional Techniques

REVIEW

Interventional endoscopic ultrasonography: an overview of safety and complications Marıá Victoria Alvarez-Sańchez • Christian Jenssen Siegbert Faiss • Bertrand Napoleón

•

Received: 6 July 2013 / Accepted: 27 September 2013 / Published online: 7 November 2013 Ó Springer Science+Business Media New York 2013

Abstract Background In recent years, endoscopic ultrasonography (EUS)-guided techniques have been developed as alternatives to surgical, radiologic, or conventional endoscopic approaches for the treatment or palliation of several digestive diseases. The use of EUS guidance allows the therapeutic area to be targeting more precisely, with a possible clinical benefit and less morbidity. Nevertheless, the risks persist and must be taken into consideration. This review gives an overview of the complications observed with the most established procedures of therapeutic EUS. Methods The PubMed and Embase databases were used to search English language articles on interventional EUS. The studies considered for inclusion were those reporting on complications of EUS-guided celiac plexus block (EUSCPB), EUS-guided celiac plexus neurolysis (EUS-CPN), drainage of fluid pancreatic and pelvic collections, and EUS-guided biliary and pancreatic drainage (EUS-BD and EUS-PD). Variations in methodology and design in most studies made a thorough statistical analysis difficult. Instead, a frequency analysis of complications and a critical discussion were performed.

M. V. Alvarez-Sańchez (&) B. Napoleón Department of Gastroenterology and Hepatology, Hoˆpital Prive´ Jean Mermoz, 55 Avenue Jean Mermoz, 69008 Lyon, France e-mail: [email protected] C. Jenssen Department of Internal Medicine, Krankenhaus Ma¨rkisch-Oderland, Wriezen, Strausberg, Germany S. Faiss Department of Gastroenterology and Hepatology, Asklepios Klinik Barmbek, Hamburg, Germany

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Results Although EUS-guided celiac plexus injection causes mainly mild and transient complications, growing experience shows that EUS-CPN is not as benign a procedure as previously thought. Most of the major complications have been observed in patients with chronic pancreatitis. The findings show that EUS-guided drainage of fluid collections is a safe procedure. Complications occur more often after the drainage of pancreatic abscesses and necrosis. Although the heterogeneity of studies dealing with pancreatobiliary drainage makes the evaluation of risks after these procedures difficult, complications after EUS-BD and EUS-PD are relatively frequent and can be severe. The technical complexity and the lack of specifically designed devices may account for their complication rates. Conclusions Clinicians can consider EUS-guided celiac injection and EUS-guided drainage of fluid collections to be safe alternatives to surgical and radiologic interventions. Well-designed prospective trials are needed to assess the risks of EUS-BD and EUS-PD accurately before they are broadly advocated after a failed endoscopic retrograde cholangiopancreatography (ERCP). Keywords Endoscopic ultrasound Celiac plexus Pancreatic collections Pelvic collections Biliary drainage Pancreatic drainage

Endoscopic ultrasonography (EUS) was initially developed in the 1980s as a diagnostic technique complementary to other cross-sectional imaging methods. Then, with the development of linear echoendoscopes, it became a method for guiding biopsies of peridigestive lesions, and the field currently is increasingly moving from a primarily diagnostic role to a therapeutic intervention role.

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The most interesting advantage of these EUS-guided procedures is that findings have shown them to be an effective and less invasive alternative to surgical or percutaneous radiologic interventions. Nevertheless, the risk of complications such as bleeding, perforation, bile leakage, and infection is increased compared with that of the diagnostic EUS [1, 2], mainly related to the complex extra-anatomic approaches. This review focuses on the current evidence of therapeutic EUS complications for the most established procedures of interventional EUS in clinical practice.

Methods An electronic literature search using the Pubmed and Embase databases identified articles focused on interventional endosonography. The search strategy involved combining all of the available literature on the technique (i.e., EUS) with the intervention type for the disease process. The keywords used with respect to the intervention type were ‘‘celiac neurolysis,’’ ‘‘celiac block,’’ ‘‘drainage,’’ ‘‘rendezvous,’’ ‘‘choledochoduodenostomy,’’ ‘‘hepaticogastrostomy,’’ ‘‘pancreaticogastrostomy,’’ and ‘‘pancreaticobulbostomy.’’ The selected keywords for the disease process were ‘‘abdominal pain,’’ ‘‘pseudocyst,’’ ‘‘necrosis,’’ ‘‘abscess,’’ ‘‘biliary obstruction,’’ and ‘‘pancreatic obstruction.’’ The review was restricted to English literature published before April 2013. The reference lists of published articles were hand-searched to select the original studies reporting on complications of EUS-guided celiac plexus neurolysis (CPN) or celiac plexus block (CPB), drainage of pancreatic and pelvic collections, and biliopancreatic drainage. Data on complications were compiled, and a frequency analysis of complications with each procedure was performed. Studies whose patients were included in further larger series were not considered. Also, series that involved fewer than 10 patients were excluded from the frequency analysis, but relevant complications published in abstracts or case reports also were described.

Results EUS-guided CPN and CPB A literature search using the terms ‘‘endoscopic ultrasound and celiac plexus neurolysis’’ or ‘‘celiac plexus block’’ yielded 104 relevant articles from the Pubmed and Embase databases. Of these studies, eight prospective studies, seven randomized controlled trials [RCTs] and five retrospective series were selected for further review. Relevant complications were also reported in seven case reports and two abstracts.

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A summary of the data extracted from the studies and included in the analysis is provided in Table 1. In 15 studies, CPN, either bilateral or at the takeoff of the celiac trunk, was performed, whereas in four series, the neurolysis was targeted at the celiac ganglia in some patients. Also, in one randomized trial, broad plexus neurolysis included the celiac and the superior mesenteric plexus. Across the 20 series comprising 1,142 patients, complications occurred in 7 % of 481 EUS-guided CPB procedures and 21 % of 661 EUS-guided CPN interventions (Table 1) [3–22]. Most of the reported complications were minor and self-limited, usually lasting less than 48 h (rarely up to 2 weeks). Minor complications were present more often after EUS-CPN (21 vs. 7 %). Among them, the most frequent were related to the blockade of sympathetic efferent activity (7 % of patients experienced transient diarrhea spontaneously resolved, and hypotension was observed in 4 % of patients). In all cases, a favorable response to intravenous fluids was observed after a short period, although some patients were offered overnight observation. One hypertensive emergency was reported, but it was thought more likely to have been due to underlying refractory hypertension and medical noncompliance [17]. Transient increase of pain occurred in 2 % of EUS-CPB and 4 % of EUS-CPN cases. The pain started generally in the recovery room and could last up to 48 h, requiring temporarily higher analgesic doses or, more rarely, hospitalization. Whether direct injection in the ganglia induces more pain or whether the immediate pain during the procedure is associated with a longer-lasting relief of pain remains controversial [7–22]. Inebriation, an uncommon complication, was reported by two Japanese groups in seven patients [15]. Major complications were rare and observed in only 0.6 % of cases after EUS-CPB and in 0.2 % of cases after EUS-CPN. However, other serious and lethal complications have been presented in case reports or abstracts. Table 2 shows all the major complications reported in the literature. A retroperitoneal abscess occurring after EUS-CPB was diagnosed in four patients, who subsequently did well after drainage and a course of intravenous antibiotics [6, 9, 23]. Also, three cases of empyema developing 37–59 days after EUS-CPB were noted more recently [24]. The spread of infection from the celiac area into the thorax due to the negative intrathoracic pressure was the pathogenic mechanism suggested by the authors. The only infectious event after EUS-CPN was a brain abscess successfully treated with antibiotic and antifungal therapy [25]. In this case, hematogenous spread of microorganisms from the upper gastrointestinal tract was aided by cellular immunodeficiency (lymphocytopenia).

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Table 1 Complications from reported series of endoscopic ultrasonography (EUS)-guided CPN/CPB Author

Study

Patients

CPN/ CPB

Followup (weeks)

Major complications

Minor complications Diarrhea

Hypotension

Pain exacerbation

Wiersema and Wiersema [3]

P

30

CPN

10

–

3

–

1

Gress et al. [4]

RCT

10

CPB

15

–

3

1

–

Gunaratnam et al. [5]

P

58

CPN

24

–

9

11

–

Gress et al. [6]

P

90

CPB

52

1 Abscess

3

–

–

Levy et al [7]

R

36

18 CPN

4–10

–

2

6

7

4

6

6

18 CPBa Leblanc et al. [8]

RCT

51

CPB

–

–

–

–

–

O’Toole and Schmulewitz [9]

R

158

31 CPN

4

–

–

1

–

1 Abscess

–

0

2

24

–

2

1

–

1

1 Retroperitoneal bleeding

–

–

–

Santosh et al. [10]

P

56

Sahai et al. [11]

P

160

128 CPB CPB 72 CPN 88 CPB

Other

–

Sakamoto et al. [12]

RCT

67

CPNb

4

–

–

–

–

Ascunce et al. [13]

R

64

CPNc

4

–

15

1

1

Leblanc et al. [14]

RCT

50

CPN

–

–

14

1

–

Iwata et al. [15]

R

47

CPN

–

–

11

8

–

Wyse et al. [16]

RCT

48

CPN

12

–

–

–

–

Stevens et al. [17]

RCT

40

CPBd

24

1 Gastric hematoma

WiechowskaKozlowska et al. [18]

R

29

CPN

8–12

–

3

1

2

Zou et al. [19]

P

27

CPN

–

–

–

1

–

LeBlanc et al. [20]

P

20

CPNe

–

–

2

–

–

1 Lightheadedness, 3 vomiting

Seicean et al. [21]

P

32

CPN

–

–

–

–

–

–

Doi et al. [22]

RCT

68

CPNf

1– 9

–

5

3

17

3 Inebriation, 1 puncture-site bleeding

Total

1,142

4

4 Inebriation 1 Hypertensive emergency

481 CPB

0.6 %

2%

2%

2%

0.2 %

661 CPN

0.2 %

10 %

5%

4%

2%

CPN celiac plexus neurolysis, CPB celiac plexus block, P prospective, R retrospective, RCT randomized controlled trial, EUS endoscopic ultrasonography a

Direct ganglia neurolysis or block (injection directly into the ganglia)

b

Broad plexus neurolysis (BPN) including the superior mesenteric plexus using a 25-G needle

c

Direct ganglia neurolysis in 40 patients and bilateral injection at the celiac trunk in 24 patients

d

21 patients received EUS-CPB with triamcinolone and bupivacaine, and 19 patients received EUS-CPB with bupivacaine alone

e

Direct ganglia neurolysis in 10 patients and CPN in 10 patients

f

Direct ganglia neurolysis in 30 patients and CPN in 38 patients

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Table 2 Major complications of endoscopic ultrasonography (EUS)-guided CPN/CPB Authors

Complication

Indication

Procedure

Gress et al. [6]

1 Retroperitoneal abscess

CP

EUS-CPB

Mahajan et al. [24]

3 Empyema

CP

EUS-CPB

Muscatiello et al. [23]


PC

EUS-CPN EUS-CPB

O’Toole and Schmulewitz [9]


CP

Sahai et al. [11]

1 Retroperitoneal bleeding

CP

EUS-CPN

Ahmed et al. [26]

1 Ischemia

CP

EUS-CPN

Lalueza et al. [25]

1 Brain abscess

CP

EUS-CPN

Kiriluk et al. [27] Gimeno-Garcıá et al. [29]

1 Ischemia

PC

EUS-CPN

1 Ischemia

CP

EUS-CPN

Loeve and Mortensen [28]

1 Ischemia

CP

EUS-CPN

Mittal et al. [30] Fujii et al. [31]

1 Paraplegia 1 Paraplegia

PC PC

EUS-CPN EUS-CPN

CPN celiac plexus neurolysis, CPB celiac plexus block, CP chronic pancreatitis, PC pancreatic cancer

One of the most serious complications was a single episode of self-limited retroperitoneal bleeding by trauma to the left adrenal artery during EUS-CPN [11]. The anticoagulation treatment in this patient was stopped immediately before the procedure, but the patient bled when the treatment was restarted several days later. Moreover, a gastric hematoma developed in one patient after EUS-CPN, which was conservatively managed [17]. Ischemia-related complications with severe visceral injury were reported four times [26–29]. In one patient, end-organ ischemia involved the spleen, pancreas, and gastric antrum after EUS-CPN [26]. Similarly, extensive ulceration and inflammation along the lesser curvature suggestive of ischemic injury was noted after EUS-CPN in another patient [27]. In the third case, emergent surgery 12 days after EUS-CPN showed a large perforation of the necrotic posterior wall of the stomach and profuse bleeding from a necrotic area of the aorta above the celiac artery [28]. Because this patient underwent two sessions of CPN, 25 and 12 days respectively before admission, the authors hypothesized that the alcohol volume injected might have been a risk factor. Complete thrombosis of the celiac takeoff was demonstrated by computed tomography (CT) in the fourth case, leading to hepatic, splenic, and right kidney infarctions and pneumatosis of the gut [29]. The last two complications were the only lethal ones of EUS-CPN reported in the literature. Diffusion of ethanol into the celiac artery and subsequent arterial vasospasm, the sclerosing effect of absolute alcohol, and arterial embolisms after injections were the plausible mechanism of the ischemic injury. Finally, two cases of acute paraplegia after EUS-guided CPN have been reported [30, 31]. The postulated mechanism of spinal cord injury in these cases involved spasm of radicular arteries due to propagation of alcohol, although

prolonged hypotension might also have contributed in one case. EUS-guided drainage of pancreatic fluid collections (PFCs) Of the 174 articles retrieved, 26 studies (6 prospective and 17 retrospective) were selected. The remaining three papers published results of RCTs comparing transmural endoscopic drainage with EUS-guided drainage, single-step with twostep EUS-guided drainage, and EUS-guided drainage using forward-viewing echoendoscopes with EUS-guided drainage using oblique-viewing echoendoscopes. The studies included in the review are summarized in Table 3. Because a number of patients in some series underwent endoscopic necrosectomy after the EUS-guided drainage, it was difficult to assess the complications of these two different procedures. Therefore, these series were not included in the review. Other papers did not differentiate between complications of EUS-guided and conventional endoscopic drainage, and these papers were also excluded. A total of 926 patients underwent EUS-guided drainage of PFCs, which had a pseudocyst in 717 cases, an abscess in 161 cases, and a postnecrotic collection in 48 cases (Table 3) [32–57]. Transmural access was performed using electrocautery with either a cystotome or a needleknife (476 patients) or by graded transmural dilation (345 patients). In two studies, the access technique was not described [38, 49]. The characteristics and numbers of the stents used are presented in Table 4. After exclusion of stent migration and PFC recurrence, procedure-related complications were reported in 78 patients (8 %; range, 0–26 %). Because one study pooled the types of EUS-guided drainage complication with those

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of conventional endoscopy drainage, the patients from this series are excluded from the following data about the different complications [38]. The most common adverse events were the infectious complications, observed in 4 % (range, 0–26 %) of the patients. Among them abscesses were developed in 31 patients (3.5 %). Three patients presented with transient fever. Three other patients experienced peritonitis, and one patient had sepsis. Occlusion of small-caliber plastic stents and stent migration are recognized causes of secondary infection leading to an abscess. Most of the studies used double-pigtail or straight plastic stents. Patients undergoing drainage with plastic stents had an abscess in 4 % of the cases (range, from 0–26 %) and an average migration rate of 5 %. Four series reported their experience with self-expanding metallic stents (SEMS) [50, 52, 54, 55]. In three of these series, the SEMS deployed was a partially (PC-SEMS) or fully covered biliary metal stent (FC-SEMS) [50, 54, 55]. The rates of secondary abscess were respectively 5, 9, and 0 %, and the stent migration rates were 5, 14, and 0 %. The fourth study showed the preliminary experience with a novel lumen-apposing stent specifically designed for drainage of a pseudocyst [52]. Stent migration was observed in one patient (7 %). The two other main complications, perforation and bleeding, occurred soon after EUS-guided drainage. Perforation was a rare complication, observed in 1.6 % of the cases overall. In half of these cases (7 of 14) surgery was required. Bleeding was reported in 17 patients (2 %) and endoscopically controlled in 6 patients. One patient underwent radiologic embolization, and two other patients required surgical treatment. The remaining eight patients did not need any treatment besides blood transfusion. The perforation and bleeding rates of electrocautery and transmural dilation techniques were 2 vs. 1.8 % and 2 vs. 1.5 %, respectively. No deaths were reported after EUS-guided drainage of pseudocysts. Complications after EUS-guided drainage and conventional transmural drainage did not differ statistically in one RCT, although a trend toward a higher rate was observed in the latter group (7 vs. 10 %; p = 0.67) [42]. Another RCT comparing conventional and EUS-guided drainage (not included in the overall analysis because the patients were pooled in a further, larger series) also failed to show differences in terms of complications [58]. The two bleeding events and the perforation during conventional transmural drainage in this study occurred in patients with nonbulging pseudocysts. In both cases, electrocautery was applied in contrast to the EUS-guided drainage group, in which a noncautery needle was used. In the other RCT, fewer complications were described after drainage with a forward-viewing echoendoscope, but the difference was not

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statistically significant (0 vs. 8 %; p = 0.56) [45]. Also, complications occurred only after two-step EUS-guided drainage using a echoendoscope to access the pseudocyst followed by replacement with a duodenoscope for insertion of the stents (12 vs. 0 % after one single-step EUS-guided drainage with an echoendoscope; p \ 0.05) [48]. EUS-guided drainage of pelvic collections and abscesses Three suitable articles consisting of three retrospective studies were identified. A total of 51 patients with EUSguided drainage of a pelvic abscess were reported in these series (Table 5) [59–61]. The patient cohort included 39 patients for whom ultrasound- or CT-guided drainage was not possible due to an inadequate window [60, 61]. Access to the collection was obtained using electrocautery in 12 patients and graded dilation in 39 patients. No major complications were observed. Only one patient experienced transient pain after drainage without radiologic signs of perforation. Fever, which lasted only 1 day, occurred in two other patients. Recurrence was observed only in case of aspiration without dilation or stenting (3 of 6 patients). EUS-guided biliary drainage (EUS-BD) The primary search identified 188 publications. Titles and abstracts were screened for relevance, and 135 records were excluded. After a full-text review of the 53 remaining studies, 20 papers were determined to be eligible for inclusion in the study [62–81]. The selected studies comprised 9 retrospective series, 10 prospective trials, and 1 RCT comparing EUS-BD and percutaneous drainage. The technique used was EUS-guided rendezvous (EUS-RV) in five studies, EUS-guided choledochoduodenostomy (EUSCD) in four studies and EUS-guided hepaticogastrostomy (EUS-HG) in another study. The remaining series included EUS-RV as well as transluminal drainage cases, either transgastric or transduodenal. Three additional articles reporting on relevant complications were also identified [82–84]. Given the heterogeneity of the studies, when considering EUS-BD complications, we decided to group the patients, first, based on the approach to the biliary system (intra or extrahepatic) and second, depending on the route of drainage used. Table 6 shows the data for intrahepatic EUS-BD [62– 91]. There were 11 studies involving 183 cases. The overall complication rate was 18 % (range, 0–36 %) including pneumoperitoneum (5 %), bile leakage (4 %), bleeding (4 %), stent dysfunction (2 %), infectious complication (2 %) and liver hematoma (1 %).

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Table 3 Complications of endoscopic ultrasonography (EUS)-guided drainage of pancreatic fluid collections (PFCs) Authors

Study

Patients

Type of fluid collection

Follow-up (months)

Total complication rates (%)

Pfaffenbach et al. [32]

R

11

Pseudocyst

4

0

Giovannini et al. [33]

R

35

Pseudocyst (15), abscess (20)

27

3

1 Perforation

Azar et al. [34]

R

23

Pseudocyst

4

1 Perforation (surgery)

Antillon et al. [35]

P

33

Pseudocyst

12

15

2 Perforations (1 surgery), 3 bleedings

Kruger et al. [36] 2006

P

35


24

26

9 Abscesses

Kahaleh et al. [37]

P

46

Pseudocyst

11

17

2 Perforations, 2 bleedings, 4 abscesses

Hookey et al. [38]

R

51

Chronic pseudocyst (37), abscess (4), acute pseudocyst/necrosis (10)

C6

12

(complications are not detailed)

Ahlawat et al. [39]

R

11

Pseudocyst

4

0

Lopes et al. [40] Barthet et al. [41]

R P

51 28

Pseudocyst (30), abscess (21) Pseudocyst

10 11

11 25

1 Perforation (surgery), 5 abscesses 2 Bleedings, 5 abscesses

Park et al. [42]

RCT

39

Pseudocyst

25

3

1 Bleeding

Yong Ahn et al. [43]

R

47


17

11

2 Perforations, 1 bleeding, 1 peritonitis

Varadarajulu et al. [44]

R

148

Pseudocyst (72), abscess (38), necrosis (38)

5

2 Perforations (2 surgeries),1 bleeding, 4 abscesses

Voermans et al. [45]

RCT

52

Pseudocyst

10–12

4

1 Bleeding, 1 mediastinal emphysema

Heinzow et al. [46]

R

42

Pseudocyst (24) abscess (18)

3–5

5

2 Bleedings

Seicean et al. [47]

P

24

Pseudocyst (15) / abscess (9)

18

17

1 Perforation (surgery), 2 bleedings, 1 abscess (surgery)

Mangiavillano et al. [48]

RCT

21

Pseudocyst

3

5

1 Bleeding

Rasmussen et al. [49]

R

22

Pseudocyst

8

9

2 Abdominal pain

Fabbri et al. [50]

P

21

Abscess

22

10

1 Abscess, 1 sepsis

Puri et al. [51]

R

40


48

8

1 Perforation, 1 bleeding, 1 fever

Itoi et al. [52]

R

15

Pseudocyst

5–19

0

Khashab et al. [53]

R

10

Pseudocyst

2

0

Weilert et al. [54]

R

18


1.5–2

0

Penn et al. [55]

R

22

Pseudocyst

15

2 Abscesses (surgery), 1 fever

Binmoeller et al. [56] Kato et al. [57]

R

14

Pseudocyst

14

1 Peritonitis (surgery), 1 fever

2

1 Perforation (surgery)

Total

R

67

Pseudocyst

926

Overall complications rate, 8 % (perforation, 1.6 %; bleeding, 2 %; infectious complications, 4 %)a

34

R retrospective, P prospective, RCT randomized controlled trial a After exclusion of the 51 patients from the study of Hookey et al. [38], in which complications of EUS-guided drainage and conventional endoscopic drainage were not differentiated

The data for extrahepatic EUS-BD are listed in Table 7, with 19 studies reporting on 341 cases [62, 64–81]. Complications were observed in 14 % (range, 3–47 %) of the

cases. These included bile leakage (5 %), pneumoperitoneum (4 %), infection (2 %, with 1 death), acute pancreatitis, bleeding, and other (1 % each).

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Table 4 Stent characteristics and infectious complications Authors

Patients

Type and number of stents

Infectious complications (%)

Stent migration (%) (surgical rescue)

Pfaffenbach et al. [32]

11

One double-pigtail

0

–


35

One 7-Fr Nasocystic catheter or one straight 8.5-Fr plastic stent

0

0

Azar et al. [34]

23

One to four 10-Fr double-pigtail

0

0

Antillon et al. [35]

33

One or two 10-Fr double-pigtail

0

0

Kruger et al. [36]

35

One straight 8.5 plastic stent

9 (26)

0

Kahaleh et al. [37]

46


4 (9)

1 (2)

Ahlawat et al. [39]

11

One 10-Fr double-pigtail

0

(0) 3 (27) (2) Lopes et al. [40]

51

One straight 10-Fr plastic stent or one 10-Fr doublepigtail

5 (10)

8 (13) (3)

Barthet et al. [41]

28

Two 7-Fr double-pigtail

5 (18)

0

Park et al. [42]

39

Two 7 Fr double pig-tail

0

1 (3)

Yong Ahn et al. [43]

47

One to four 7-Fr double-pigtail

0

(0) 0

Varadarajulu et al. [44]

148

One to three 7- or 10-Fr double-pigtail

4 (3)

Voermans et al. [45]

52

One to three 7-Fr double-pigtail

0

Heinzow et al. [46]

42

One 10-Fr double-pigtail

0

1 (1) (0) 0 6 (14) (NR)

Seicean et al. [47]

24

One 8.5-Fr double-pigtail or 7-Fr nasocystic catheter

1 (4)

1 (4) (1)

Mangiavillano et al. [48]

21

One of 7- or 10-Fr double-pigtail

0

0

Rasmussen et al. [49]

22


1 (5)

Fabbri et al. [50]

21

10-mm CSEMS

1 (5)

1 (5)

Puri et al. [51]

40

1 (3)

0

Itoi et al. [52]

15

One 10-Fr double-pigtail and one 7-Fr naso pigtail drainage tube 10-mm FC-lumen-apposing stent

0

1 (7)

Weilert et al. [54]

18

10-mm FCSEMS

0

Penn et al. [55]

22

10-mm CSEMS

2 (9)

4 (9) (NR) (1)

(NR) 0 3 (14) (0) Binmoeller et al. [56]

14

Two 7-Fr double-pigtail

1 (7)

0

NR number of patients not reported, CSEMS covered self-expanding metal stent, FC fully covered, FCSEMS fully covered self-expanding metal stent

We evaluated only three routes of drainage (EUS-RV, EUS-CD, and EUS-HG). Although anterograde drainage, hepaticoesophagostomy, hepaticojejunostomy, and choledochogastrostomy have also been described, the number of reported cases was too small. A total of 326 patients underwent EUS-BD by a rendezvous procedure, and

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complications occurred for 11 % (range, 0–22 %) of these patients (Table 8) [64, 68, 70–72, 74, 75, 77, 78, 82]. The most frequent complication was acute pancreatitis (3.4 %). Other complications were bile leakage (2.7 %), pneumoperitoneum (2 %), infections (1 %), and bleeding (0.9 %).

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Table 5 Results of endoscopic ultrasonography (EUS)-guided drainage of pelvic abscesses Author

Study

Patients

Access technique

Type/number of stents

Success rate (%)

Follow-up (months)

Recurrence

Complications


R

12

Needleknife

8.5-Fr straight plastic stent (5)

75

18

2a

25 % 1 Abdominal pain, 2 fever

96

7

0

0%

92

6

1a

0%

10-Fr double-pigtail (3) 8.5- and 10-Fr stents (1) Only aspiration (3) Varadarajulu and Drelichman [60]

Puri et al. [61]

R

R

25

14

Transmural graded dilation

One 7-Fr doublepigtail (7)

Transmural graded dilation

10-Fr double-pigtail (9)

Two 7-Fr doublepigtail (18)

Dilation ? aspiration (2) Only aspiration (3)

R retrospective a

These patients underwent only aspiration of the abscess

Transmural drainage was performed in 281 patients (177 EUS-CD and 104 EUS-HG), with respective complication rates of 19 % (range, 8–100 %) and 24 % (range, 0–36 %). The overall complication rate for transmural drainage was 21 % (Tables 9, 10). Bile leakage was the most frequent complication (7 % for both routes of drainage) followed by pneumoperitoneum (6 % for both procedures). Other complications in the choledochoduodenostomy group were cholangitis (3.4 %), bleeding (2 %), and others (2 %). Bleeding (5 %), liver hematomas (2 %), infection (2 %), and others (3 %), were reported in the hepaticogastrostomy group. In one series, EUS-BD-related deaths were registered for six patients (1 %) due to bile peritonitis (n = 2), perforation (n = 22), massive intraperitoneal bleeding (n = 21), and sepsis (n = 21) [70]. The drainage route was not always reported. Three other deaths are also described in the literature. In a case report, after a EUS-BD with intrahepatic abscess, one death occurred due to peritonitis after migration of a covered SEMS [83]. The two remaining deaths were reported in a short series due to postprocedural cardiogenic shock and bile leakage [84]. All the studies used 19- or 22-gauge fine-needle aspiration for initial duct puncture. For transmural drainage, four studies performed graded dilation of the newly created fistula with the endoscopic retrograde cholangiopancreatography (ERCP) cannula, biliary dilator catheters, or balloon dilators in all patients. However, the majority of the studies used electrocautery for fistula dilation, either as the only technique or in combination with graded dilation using catheters or balloons. The stents placed were mostly

plastic stents (straight, single, or double-pigtail), with diameters ranging from 5 to 10 Fr. SEMS (uncovered (UC-SEMS), PC-SEMS, or FC-SEMS) were evaluated in five recent studies, and either a plastic or a metal stent was placed in three other series. The inter- and intrastudy heterogeneity of devices used make it difficult to evaluate their potential impact on complications of EUSBD. Only one study focused on risk factors for adverse events [67]. In this study, the use of a needleknife for fistula dilation was the single factor associated with postprocedural complications (odds ratio [OR], 12.4; p = 0.01), and the location of the fistula (gastric body for EUS-HG versus duodenum for EUS-CD) was a predictive factor for successful graded dilation (OR, 0.062; p \ 0.0001). Adverse events were also more frequent in benign conditions (50 vs. 16 %), although the difference was not statistically significant. One prospective trial randomized 25 patients to percutaneous transhepatic (PTBD) or EUS-guided biliary drainage [78]. The complication rates did not differ between the two groups, although a trend toward a higher rate was observed in the PTBD group (15 vs. 25 %; p = 0.44). EUS-guided pancreatic duct drainage (EUS-PD) The Pubmed and Embase search found 22 original articles reporting on patients who had undergone EUS-PD. Only eight of these articles (7 retrospective studies and 1 prospective study) fitted the criteria for inclusion in the study

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Table 6 Studies evaluating endoscopic ultrasonography (EUS)-guided intrahepatic access for biliary drainage Author

Study

Patients

Rendezvous drainage

Transmural drainage

Successful EUS biliary drainage %

n

Follow-up (months)

Procedure-related complications

Kahaleh et al. [62]

R

13

NR

1 HG, ATP, NR

92

12

[1

8 % Bleeding (1)

Bories et al. [63] Maranki et al. [64]

R

11

–

11 HG

91

10

8

P

40

26

3 HG

73

29

9

36 % Bile leakage (1), cholangitis (1), stent occlusion (1), ileus (1) 10 % Aspiration pneumonia (1), minor bleeding (1), pneumoperitoneum (3)

Horaguchi et al. [65]

P

7

–

5 HG, 2 HE

100

7

5

14 % Stent migration (1)

Ramirez– Luna et al. [66]

P

2

–

2 HG

100

2

\1

50 % Stent migration (1)

Park et al. [67]

P

31

–

31 HG

100

31

7

19 % Pneumoperitoneum (4), bleeding (2)

Iwashita et al. [68] Kim et al. [69]

R

9

4a

–

–

R

4

4 HG

75

3

Vila et al. [70]

R

34

34 HG

65

22

29 %b Bile leakage (3), bleeding (3), abscess (1) Pneumoperitoneum (2), liver hematoma (2)

Park et al. [71] Kawakubo et al. [72]

P

29

3

14 HG, 9 ATP

90

26

7 % Bile leakage (2)

P

3

3

100

3

0%

183

Success rate: 81 % (145/179)a

Total

11 % Pneumoperitoneum (1) 5


Complication rate: 18 % (34/183)

R Retrospective, NR number of patients not reported, HG hepaticogastrostomy, ATP anterograde transpapillary drainage, P prospective, HE hepaticoesophagostomy a

Results from the series by Iwashita et al. [68] were not included in the overall success rate because when the rendezvous technique failed, transmural drainage was not attempted

b

A total of six deaths were reported in this series, but the biliary approach in these cases was not detailed

(Table 11) [82, 85–90]. In one study, EUS-RV was the only technique performed. In two other studies, EUS-RV was always attempted at first, with transluminal drainage attempted after an EUS-RV failure. Transluminal drainage, either EUS-PG or EUS-PB, were the only procedures in two reports, and EUS-RV or transluminal drainage was performed in two series depending on the anatomic considerations (accessible or inaccessible papilla), with crossover when the intended procedure failed in one of them. Overall, complications were observed in 21 of 126 patients (16 %; range, 7–46 %). These complications included acute pancreatitis (3 %), bleeding (2 %), perforation (2 %), postintervention pain (3 %), and others (2 %). No procedure-related deaths were reported, and only one of these complications (severe acute pancreatitis) required surgical treatment. Selective angiography with embolization of an aneurysm was performed to avoid its rupture.

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Although no clear differentiation between rendezvous and transluminal procedures was made when complications were reported in the majority of the studies, the series that first attempted EUS-RV whenever feasible showed the lowest incidences of adverse events (range, 7–10 %) [88– 90]. Plastic stents, either straight or pigtail stents, were used for transmural stenting in all cases, with calibers ranging from 5 to 10 Fr. Three studies reported stent-related complications in long-term follow-up evaluation. In these studies, stent dysfunction was the most frequent adverse outcome (50–100 %), requiring repeated procedures for exchange of the stent. In the study by Kahaleh et al. [85], 10 patients with successful drainage (100 %, 10/10) returned as required when their symptoms recurred, and a mean of two interventions to exchange the stent were performed. Tessier et al. [87] reported 31 events of stent dysfunction in 20 patients (55 %). The main problems were either stent obstruction (n = 11) or

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Table 7 Endoscopic ultrasonography (EUS)-guided extrahepatic access for biliary drainage Author

Study

Patients

EUS-RV drainage

Transmural drainage

Successful EUS-BD

Follow-up (months)


Kahaleh et al. [62]

R

10

NRa

1 CD, 1 CG, ATP, NR

90 % (7 RV ? 1 CD ? 1 CG)

[1

30 % Bile leakage (1), pneumoperitoneum (2)

Maranki et al. [64]

P

14

8

4 CD/CG

86 %

9

21 % Bile leakage (1), pneumoperitoneum (1), abdominal pain (1)

Brauer et al. [73]

R

(12) 92 %

\1

17 % Pneumoperitoneum (1), cardiorespiratory failure (1)


P

5


Kim et al. [74]

R

15

12b

Komaki et al. [75]

R

15

1

Hara et al. [76]

P

18

12

NRa

9

3 CD, ATP, NR 8 CD, 1 CG

(11) 100 % (9)

7 % Pancreatitis (1) 14 CD

100 %

4

47 % Bile leakage (2), cholangitis (4), stent migration (1)

6

17 % Bile leakage (2), hemobilia (1)

6

6 % Pneumoperitoneum (1)

3

22 % Bile leakage (1), stent migration (1)

7

19 % Bile leakage (2), pneumoperitoneum (3)

(14 CD ? 1 RV) 18 CD

94 % (17)

Fabbri et al. [77]

P

Ramirez–Luna et al. [66]

P

Park et al. [67]

P

16

3

12 CD, 1 CG

75 % (9 CD ? 3 RV)

9

9 CD

89 % (8)

26

24 CD

92 % (24)

Iwashita et al. [68]

R

31

25b

Dhir et al. [78]

R

58

57b

Kim et al. [69]

R

9

13 % Pancreatitis (2), abdominal pain (1), sepsis (death) (1) 9 CD

100 %

C3


5

11 % Pneumoperitoneum (1)

2.5

15 % Bile leakage (1), bleeding (1)

6

47 % Pneumoperitoneum (2), cholangitis (1)

(9) Artifon et al. [79]

RCT

Song et al. [80]

R

13

13 CD

100 % (13)

15

14 CD

93 % (14/15)

Vila et al. [70]

P

26c

Park et al. [71]

P

16

13

Kawakubo et al. [72]

P

11

11

Hara et al. [81]

P

18

26 CD

86 % (19)

15 % Bile leakage (1), bleeding (1), acute pancreatitis (1), cholangitis (1)d

3 CD

94 % (13 Rv ? 2 CD)

19 % Bile leakage (1), pneumoperitoneum (1), acute pancreatitis (1)

100 %

18 % Bile leakage (1), acute pancreatitis (1)

(11) 18 CD

100 %

6


(18) Total

341

Success rate, 87 % (216/247)

Complication rate, 14 % (49/341)

RV rendezvous, R retrospective, NR number of patients not reported, CD choledocoduodenostomy, CG choledocogastrostomy, ATP anterograde transpapillary drainage, RCT randomized controlled trial, P prospective a

The number of EUS-RV and anterograde transpapillary procedures was not reported

b

The results from these series were not included in the total success rate because when the rendezvous technique failed, transmural drainage was not attempted

c

60 patients with a rendezvous procedure in this series were excluded from this table because the route of access was not reported

d

A total of 6 deaths were reported in this series, but the biliary approach in these cases was not detailed

stent migration (n = 16). The stents were not exchanged in eight patients (failure in 2 patients and change no longer indicated in 6 patients). Also, 50 % of the patients (n = 9) in

the series by Ergun et al. [89] needed stent exchange or repeated procedures due to occlusion in seven patients and migration in the remaining two patients.

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Table 8 Endoscopic ultrasonography (EUS)-guided biliary drainage by rendezvous procedure Author

Study

Patients

Biliary access

Maranki et al. [64]

P

54

Intrahepatic (40), extrahepatic (14)

Successful rendezvous drainage 73 % (34)

15 % Bile leakage (1), pneumoperitoneum (self-limited) (4), bleeding (1), abdominal pain (1), aspiration pneumonia (1)

Kim et al. [74]

R

15

Extrahepatic

Komaki et al. [75]

R

1

Extrahepatic

100 % (1)

0%

Fabbri et al. [77]

P

12

Extrahepatic

25 % (3)

0%

Iwashita et al. [68]

R

40


73 % (29)

13 % Pancreatitis (2), abdominal pain (1), sepsis (death) (1)

Dhir et al. [78] Shah et al. [82]

R R

58 52

Extrahepatic

98 % (57) 75 % (39)

4 % Bile leakage (2) 12 % Bile leakage (1), pneumoperitoneum (surgery) (1), acute pancreatitis (4)

Vila et al. [70]

R

60

68 % (41)

22%a Bile leakage (3), pneumoperitoneum (2), bleeding (2), cholangitis (2), acute pancreatitis (2)

Park et al. [71]

P

20


80 % (16)


Kawakubo et al. [72]

P

14


100 % (14)


Success rate: 75 % (246/326)

Complication rate: 11 % (36/326)

Total

326

80 % (12)

Procedure-related complications (n)

7 % Pancreatitis (1)

P prospective, R retrospective a


A high incidence of pancreatic cancer was observed during the follow-up period in two series. Tessier et al. [87] reported that four of eight patients with no improvement in their symptoms had a subsequent diagnosis of cancer. Also, in the series by Ergun et al. [89], pancreatic carcinoma was diagnosed in three patients 3 to 6 months after EUS-PD.

Discussion EUS-guided CPB and CPN Abdominal pain, the most common symptom among patients with chronic pancreatitis and pancreatic malignancy, can be severely incapacitating and entails a significant reduction in quality of life. The mainstay of treatment for these patients involves narcotic analgesics, but they have shown limited efficacy, and many concerns arise from their side effects. Injection of ethanol (neurolysis: CPN) or corticoids (blockage: CPB) at the celiac plexus, with the goal of destroying or temporarily blocking the visceral afferent transmission of the pain from the pancreas, has been introduced as an alternative method. Traditionally, CPN and CPB were performed using percutaneous or intraoperative techniques by radiologists

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and surgeons. Currently, the EUS-guided approach, due to anatomic advantages, offers the most direct nonsurgical access to the celiac plexus and is thought to have fewer complications. However, the only two studies comparing percutaneous and EUS-guided approaches suggest better and more persistent pain relief with the EUS-guided technique, probably due to the easier localization of the celiac plexus, but failed to show significant differences in the complication rates between the two techniques [4, 10]. The majority of complications are mild and mostly related to the blockade of sympathetic efferent activity. They are observed more frequently after EUS-CPN, as may be expected due to the potent neurolytic effect of absolute alcohol. The exacerbation of pain in our study, although less frequent, was not uncommon. Some authors have suggested that the immediate pain during the procedure can be explained by a more effective neuronal destruction [7]. Therefore, the question remains whether the transient pain lasting 1 or 2 days and the subsequent palliation of pain, self-limited diarrhea, or transient asymptomatic hypotension are true complications, or whether the pain should be categorized as an expected side effect of these procedures. Several precautions have been advised to minimize the aforementioned side effects. Adequate intravenous hydration

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Table 9 Endoscopic ultrasonography (EUS)-guided choledochoduodenostomy Author

Study

Patients

Puncture device (n)

Stent (n)

Successful EUS-CD


Kahaleh et al. [62]

R

1

19-G FN

10-Fr PS

100 % (1/1)

100 % Pneumoperitoneum (selflimited) (1)

Brauer et al. [73]

R

3

19- to 22-G FN, NK

5- to 10-Fr PS

100 % (3/3)

67 % Pneumoperitoneum (selflimited) (1), cardiorespiratory failure (1)


P

8

19-G FN balloon dilator/biliary dilator

7-Fr PS

100 % (8)


Komaki et al. [75]

R

15

19-G FN (6), NK (9)

7-Fr PS

93 % (14/15)

47 % Cholangitis (4), bile leakage (2), stent migration (1)

Hara et al. [76]

P

18

NK

7- to 8.5-Fr PS

94 % (17)

17 % Bile leakage (2), hemobilia (1)

Fabbri et al. [77]

P

13

19-G FN, NK

PCMS

69 % (9/13)



P

9

19-G FN ? 6-, 7-, or 10-Fr biliary dilator, 8-mm balloon dilator

7-, 8-, or 10-Fr PS

89 % (8/9)


Park et al. [67]

P

26

19-G FN ? 6- to 7-Fr biliary dilator (5), NK (19)

7-Fr PS (12), 10-mm FCMS (12)

92 % (24/26)

19 % Bile leakage (2), pneumoperitoneum (self-limited) (3)

Kim et al. [69]

R

9

19-G FN ? NK or cystotome (8), tapered ERCP canula (1)

10-mm FCMS

100 % (9/9)


Artifon et al. [79]

RCT

13

19-G FN, NK

10-mm PCMS

100 % (13/13)

15 % Bile leakage (1), bleeding (1)

Song et al. [80]

R

15

19-G FN ? 6- to 7-Fr biliary dilator, NK

7-Fr PS (1), 8-mm (13) & 10-mm (1) FCMS

Vila et al. [70]

P

26

Park et al. [71]

P

3

19-G FN ? NK, 6- to 7-Fr biliary dilator

8- to 10-mm FCMS

Hara et al. [81]

P

18

22-G FN, 6- to 9-Fr biliary dilator

10-mm PCMS, FCMS

177

Success rate: 85 % (151/177)

Total

93 % (14/13)

47 % Pneumoperitoneum (selflimited) (2), cholangitis (1)

86 % (19/26)

15a % Bile leakage (1), bleeding (1), acute pancreatitis (1), cholangitis (1)

67 % (2/3)


100 % (18/18)

28 % Bile leakage (2) Complication rate: 19 % (34/177)

CD choledocoduodenostomy, R retrospective, FN fine needle, PS plastic stent, NK needle knife, P prospective, PCMS partially covered metal stent, FCMS fully covered metal stent, ERCP endoscopic retrograde cholangiopancreatography, RCT randomized controlled trial a


with saline solution before and after the procedure is recommended to reduce the incidence of transient hypotension. Diarrhea usually resolves spontaneously, and meanwhile, antidiarrheal agents may be administrated. The administration of a local anesthetic (bupivacaine or lidocaine) reduces the discomfort caused by the alcohol, although an increased dosage of analgesics may be needed for several days after the procedure. Finally, inebriation is a rare minor complication, described only in Japanese individuals, who have a lower ability to metabolize alcohol than individuals of other races. The anterior approach used for EUS may reduce the risk of inadvertent penetration of surrounding organs and neurologic complications. However, paraplegia cannot be avoided completely because two cases after EUS-CPN

have already been reported [30, 31]. In addition, other major complications such as serious infections, retroperitoneal bleeding, and lethal ischemic injury have been observed. Most infectious events have occurred after EUS-CPB. Some authors have hypothesized that the use of acid suppression in some of these patients may have promoted the bacterial colonization of the gastric wall and the translocation at the point of the EUS-CPB procedure. Nevertheless, no consensus exists on the routine use of antibiotic prophylaxis or the discontinuation of acid suppressants before EUS-guided CPB based on the low frequency of these infectious complications. The use of steroids during EUS-CPB can also contribute to this adverse outcome. A recent RCT failed to prove any benefit from the addition of

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Table 10 Endoscopic ultrasonography (EUS)-guided hepaticogastrostomy Author

Study

Patients

Puncture device (n)

Stent (n)

Kahaleh et al. [62]

R

6

19-G FN

10-Fr PS

17 % (1/6)

0%

Bories et al. [63]

R

11

19-G FN, 6- to 8.5-Fr cystotome

PCMS (3), 7-Fr PS (1), 8.5-Fr PS (3), 10-Fr PS (3)

91 % (10/11)

36 % Bile leakage (1), cholangitis (1), stent occlusion(1), ileus (1)


P

5

19-G FN ? balloon dilator, biliary dilator

7-Fr PS

100 % (5/5)

0%


P

2

19 G FN, 6- to 7-Fr bougie

7-Fr PS

100 % (2/2)

50 % Stent migration

Park et al. [67]

P

31

19-G FN ? 6- to 7-Fr biliary dilator (23), NK (8)

7-Fr PS (6), 10-mm FCMS (25)

100 % (31)

19 % Pneumoperitoneum (self-limited) (4), bleeding (2)

Kim et al. [69]

R

4

19-G FN (1), 19-G FN ? cystotome (2), 19-G FN tapered ERCP cannula (1)

10-mm FCMS

Vila et al. [70]

R

34

Park et al. [71]

P

11

19-G FN ? 4-Fr cannula

104

Success rate: 79 % (89/104)

Total

Successful EUS-HG

10-mm UCMS


75 % (3/4)


65 % (22/34)

29 %a Bile leakage (3), pneumoperitoneum (self-limited) (2), bleeding (3), liver hematoma (2), abscess (1)

91 % (9/11)

7 % Bile leakage (2) Complication rate 24 % (25/104)

HG hepaticogastrostomy, R retrospective, FN fine needle, PS plastic stent, PCMS partially covered metal stent, P prospective, NK needle knife, FCMS fully covered metal stent, ERCP endoscopic retrograde cholangiopancreatography, UCMS uncovered metal stent a


triamcinolone to bupivacaine to improve pain relief [17]. If this is confirmed in future studies, cessation of corticoid use might decrease the infection risk. Unnoticed trauma to the left adrenal artery caused a retroperitoneal hemorrhage in one patient after EUS-CPN [11]. Some authors have argued that the hyperechocoic nature of alcohol might blur the puncture area during the second injection, leading to accidental arterial injury [14]. However, no agreement exists as to whether only one injection differs from two injections (one on either side of the celiac artery) in terms of efficacy and safety [11–14]. It is therefore advisable to use an aspiration syringe to confirm that a vessel is not punctured once the needle enters the target area. Unfortunately, no special measure exists to prevent diffusion of the alcohol into the vessels, the hypothetical mechanism of paraplegia and visceral ischemia. The latter is one of the most feared complications, reported in four patients after EUS-CPN and leading to death in two of the four [26–29]. In conclusion, EUS-CPN is not as benign a procedure as previously suggested, and it must be limited to patients with pancreatic cancers. It is also noteworthy that 73 % of major complications have occurred in the setting of chronic pancreatitis (Table 2). Appropriate patient selection and

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careful attention when celiac injection is performed in patients with chronic pancreatitis are paramount. EUS-guided drainage of PFCs Symptomatic PFCs, featuring pain or mechanical obstruction of the gastric outlet or the biliary system, require drainage. The therapeutic options include surgical, percutaneous, and endoscopic drainage. Since the first report of EUS-guided drainage in 1992 [91], it has emerged as the leading treatment method for PFCs due to several advantages. First, it is less invasive than surgery, with faster recovery times and lower costs. Second, EUS-guided drainage may avoid local complications related to percutaneous drainage such as secondary infection, pancreaticocutaneous fistula, bleeding, and inadvertent puncture of adjacent viscera. Also, by avoiding interposed vessels, it may decrease the bleeding rate associated with the blind procedure of conventional endoscopic drainage. Third, EUS can differentiate a pseudocyst from a cystic tumor and can depict a necrotic collection requiring additional endoscopic debridement. Therefore, in one study, it provided essential information that led to a change in the management strategy in almost 40 % of the cases [92]. Finally, it

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Table 11 Endoscopic ultrasonography (EUS)-guided pancreatic duct (PD) drainage Author

Study

Patients

First technique attempted

Transmural stent

Successful EUS-RV

Successful EUS-PD

Followup (months)

Stent dysfunction


Kahaleh et al. [85]

R

12

EUS-PG

7-Fr PS straight/ pigtail

–

83 % (10/12)

14

100 (10/10)

17 % Perforation (1), bleeding (1)

Will et al. [86]

P

13

EUS-PG, EUSRV

8.5- to 10-Fr PS straight/ pigtail

69 % EUS-PG (5), RV (4)

1–36

–

46 % Perforation (1), bleeding (1), pain (4)

Tessier et al. [87]

R

36

EUS-PG EUS-PB

6- or 7-Fr PS

92 % EUS-PG (26), EUS-PB (7)

15

60 (20/33)

14 % Hematoma (1), acute pancreatitis (1), mild unspecified complications (3)

Barkay et al. [88]

R

12

EUS-RV

Shah et al. [82]

R

22

EUS-RV, EUS-PG

PS

56 (9/16)

86 % EUS- RV (9), EUS-PG (10)

Ergun et al. [89]

R

20

EUS-RV

5- or 7-Fr PS straight/ single pigtail

25 (5/20)

90 % EUS- PG (11), EUS-PB (2), EUS-RV (5)

37

Kurihara et al. [90]

R

14

EUS-RV

7-Fr straight PS

64 (9/14)

86 % EUS-RV (9), EUS-PG (3)

–

Total

129

42 % (26/ 62)a

89 % (104/117) b

33 (3/12)

12

8 % Shaving of the guidewire coating (1) 16 % Perforation (1), acute pancreatitis (1 severe, 2 mild) 50 (9/18)

10 % Bleeding (1), perigastric collection (1)

7 % Pseudocyst with splenic aneurysm (1) 16 % (21/129)

RV rendezvous, R retrospective, PG pancreaticogastrostomy, PS plastic stent, P prospective, PB pancreaticobulbostomy a

Only patients from studies in which EUS-RV was always attempted at first

b

Excluding studies in which anterograde drainage was not tried after an EUS-RV failure

makes the endoscopic drainage of nonbulging collections possible. Vosoghi et al. [93] reviewed and compared the results in case series of surgical, percutaneous, and endoscopic drainage of symptomatic pseudocysts. These authors found that EUS-guided drainage has the lowest complication and mortality rates among the different drainage procedures, with a comparable success rate. However, the two RCTs comparing conventional endoscopic and EUS-guided drainage failed to show statistical differences with regard to complications between the two approaches, although a trend toward a higher complication rate after conventional endoscopic drainage was observed [40, 58]. In line with this finding, one metaanalysis comparing the two approaches found that the overall complications were similar in the two groups [94]. One limitation of these studies was that patients with bulging pseudocysts were likely to be subjected to conventional endoscopic drainage rather than EUS-guided drainage, whereas all the patients with nonbulging

pseudocysts underwent EUS-guided drainage. In addition, it is noteworthy that deaths occurred only with conventional endoscopic drainage, mostly due to bleeding [41, 58]. Therefore, EUS-guided drainage is preferred in cases of nonbulging pseudocysts, portal hypertension, or coagulopathy. The most frequent complication of EUS-guided drainage mainly concerns infectious events, most often resulting from stent occlusion or migration. Stent occlusion after clogging by adhesion of a bacterial biofilm or by larger pieces of necrotic tissue is the main cause of the infection. Use of EUS is helpful in selecting those patients with large pieces of necrotic tissue for a more aggressive endoscopic procedure (necrosectomy). Although patients with pseudocysts undergoing drainage should receive prophylactic antibiotics to avoid secondary infection of a sterile cavity, the main key to prevention of this complication is to keep the tract between the cyst and the gut lumen opened. Currently, the introduction of multiple prostheses seems to be the best solution because the

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pseudocyst content can drain through and also alongside the prostheses. Accordingly, in the series with the highest rate of abscesses (26 %), only one 8.5-Fr stent was deployed [35]. No series has compared the size of plastic stents. Stent migration does not often have clinical consequences, but when the migration occurs early after the drainage procedure, it can result in clinical failure or secondary infection. The overall migration rate in the series analyzed was 4 % (range, 0–18 %), and more than half of the migrations were successfully managed either with a new stent or by endoscopic retrieval of the migrated stent inside the pseudocyst after balloon dilation of the cystogastrostomy tract. The stent design may be an important consideration because migration has been largely associated with straight stents, although no comparative trials with pigtail stents have been conducted. It has also been suggested that the placement of more than one stent reduces the risk of stent migration. However, the heterogeneity of the intrastudies and comparisons between the different series regarding the number, size, and type of the stents used makes it difficult to draw any conclusion. More recently, three groups have reported their experience with the use of conventional SEMS [50, 52–54]. It has been proposed that a covered SEMS with a wider diameter may lead to faster drainage and potentially longer patency, preventing infectious events and retroperitoneal leakage. However, there is a concern that covered SEMS may have a higher migration rate due to their silicone coating. The insertion of a pigtail plastic stent inside the metal stent to prevent stent migration has been advised by some authors [55]. Another stent design, a novel, covered, lumenapposing stent with a 10-mm diameter and a dumbbell shape (Axios stent; Xlumena Inc., Mountain View, CA, USA), has been manufactured recently. The first clinical experience with the new stent shows promising results [52]. In the future, RCTs will certainly be conducted to compare the efficiency and the safety profile of plastic and SEMS. Retroperitoneal perforation often is recognized during the procedure and frequently is reported in the literature as pneumoperitoneum. It must be considered a complication only in the case of clinical symptoms because a minute amount of air is always present after endoscopic drainage, without any clinical consequence. Most often, it occurs when the pseudocyst wall does not immediately abut the gastric or duodenal walls or when the puncture is not perpendicular to the pseudocyst wall. Fortunately, this is a rare complication, observed in only 14 (1.6 %) of 875 cases, with only half of the cases requiring surgery. To minimize this risk, only fluid collections with a mature wall and within 1 cm of the gastrointestinal lumen should be treated with endoscopic drainage.

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In a recent study evaluating the reasons for complications of EUS-guided drainage of PFCs [43], perforations were found only in patients with collections in the uncinate region of the pancreas when transgastrically drained, but never with a transduodenal approach. Based on the findings at surgery, the authors inferred that although the PFCs at the uncinate process could be visualized in close proximity to the gastric wall by EUS, no real adherence between the wall of the pseudocyst and the stomach existed. After transmural stenting, the uncinate region was decompressed and the pseudocyst moved farther away from the stomach wall, leading to perforation. Therefore, transduodenal drainage seems to be a better approach for pseudocysts located at the uncinate process. Other technical aspects may add to the risk of perforation. Early experience suggested that most perforations occur during transmural puncture using electrocautery [95]. In contrast, during graded transmural dilation, access is performed over a guidewire, and the drifting of the guidewire during attempted dilation should serve as a notice that the PFC is nonadherent to the gastrointestinal wall. Balloon dilation should not then be performed, and an alternative site should be chosen for drainage. In any case, electrocautery is sometimes necessary for entrance of the cyst due to the presence of a fibrous cystic wall. In such cases, the use of an over-the-wire needleknife might minimize the risk of perforation. Currently, it is not possible to draw any conclusion because no RCT has evaluated this issue, and the number of reported perforations is low (1.7 % for graded dilation and 2 % when electrocautery is used). The oblique view of current linear echoendoscopes limits perpendicular access to the cyst cavity, which may hamper successful completion of the procedure. Puncture with a tangential axis increases the force needed to traverse the different layers and heightens the risk of tunneling between the gastric wall and the PFC, resulting in a higher risk of perforation. Recently, a forward-viewing therapeutic echoendoscope has been manufactured that allows forward axis of the needle. However, in the only randomized trial evaluating this prototype, the number of patients was insufficient to show significant differences between success and cases of complications [44]. More extensive studies are necessary to determine whether EUS-guided drainage of PFCs using a forward-viewing echoendoscope is advantageous. Bleeding is also an uncommon complication. One cause of bleeding is pseudoaneurysms in the wall of the pseudocyst that suddenly do not experience any counterpressure when the drainage has been achieved. Doppler-EUS or dynamic computed tomography (CT) must exclude this possibility before drainage. Another cause is laceration of a vessel at the entry site, usually due to interposed varices.

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This complication is essentially eliminated by using EUS guidance. Hemostasis usually can be achieved with standard hemostatic endoscopic techniques. Although a higher risk of bleeding with diathermic puncture during non-EUS-guided transmural drainage has been suggested [95], no direct comparison between the two access approaches has been performed. Moreover, bleeding has been reported in the literature, with close frequencies resulting from both approaches (2.4 and 1.4 %, respectively). The highest morbidity rates have been observed in the setting of drainage procedures for pancreatic necrosis and infected pseudocysts, as shown by Baron et al. [96] (37 % of the complications among patients with necrosis and 19 % among patients with chronic or acute pseudocysts) and Sadik et al. [97] (6 % of the complications associated with pseudocysts and 30 % associated with abscesses). However, clinical data pertaining to the drainage of only pseudocysts are scant because most studies also have encompassed cases of abscess and necrosis. Furthermore, in some series, a number of patients underwent endoscopic necrosectomy after the EUS-guided drainage, making it difficult to assess the complications of these two different endoscopic procedures [98–100]. All the aforementioned data refer to cyst-gastrostomy and cyst-duodenostomy because the usual sites from which PFCs can be accessed are the stomach and the duodenal bulb. However, in some cases, pseudocysts are present in atypical locations such as the mediastinum. Preliminary experience with transesophageal drainage of PFCs in the mediastinum has been reported in six cases [101–103]. No severe complications have been observed. Also, the satisfactory experience with EUS-guided drainage of PFCs has led to drainage of collections after pancreatectomy under EUS guidance, with similar results [104–106]. EUS-guided drainage of pelvic collections and abscesses Pelvic collections appear as a complication of colorectal surgery and several medical conditions such as inflammatory bowel disease, appendicitis, diverticulitis, and ischemic colitis. They can be drained either surgically or by noninvasive techniques such as percutaneous drainage under CT or transrectal/vaginal ultrasound guidance. Their anatomic situation usually is complex because of the surrounding organs (e.g., vagina, prostate and bladder, bones), challenging radiologists. Drainage guided by EUS is a minimally invasive alternative with two main advantages: close proximity between the probe and the collection, allowing an easy needle puncture that avoids interposed organs, and the placement of internal stents, obviating the patient discomfort related to external catheters. The technical steps in drainage of

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pelvic collections by EUS guidance are the same as those for PFCs. Special cautions before puncturing should be observed including adequate bowel preparation and emptying of the urinary bladder to minimize the risks of contamination and to facilitate the visualization of the abscess. The administration of antibiotics is also recommended. Some minor case studies in the literature evaluated the role of EUS-guided drainage of pelvic abscess, and no major complications have been reported. In the majority of these cases, EUS avoided surgical drainage in patients with abscesses unamenable to percutaneous drainage. The main adverse outcome was recurrence of the abscess when simple aspiration was performed. Therefore, it is highly advisable to place one or more stents to ensure a complete response. Recently, a successful EUS-guided approach in one patient with a pelvic abscess and a J-pouch construction for Crohn disease has been reported [107]. In patients with a J pouch, EUS-guided drainage may be technically challenging due to the altered surgical anatomy. Also, the management of pelvic abscess in the setting of inflammatory bowel disease deserves further clinical research.

EUS-guided biliary drainage Transpapillary stenting by ERCP is the standard of care for decompression in patients with obstructive jaundice due to its low rates of morbidity and mortality. Although biliary and pancreatic duct cannulation is successful in a high percentage of patients, ERCP failures are expected in 3–10 % of cases [108] depending on patient- and operatorrelated factors including a surgically altered anatomy (Roux-en-Y, Billroth II, pancreaticoduodenectomy, and bariatric diversion), impacted stones, tumor infiltration, periampullary diverticula, duodenal stenosis, and physician inexperience. In addition, after a technically successful ERCP, partial or no relief of symptoms can be observed with persistent jaundice in some patients. The rescue procedure after a failed ERCP is percutaneous transhepatic biliary drainage (PTBD) or surgical intervention. Although PTBD is fairly successful, it fails in 5–30 % of cases, especially when no dilation of the intrahepatic bile duct is present, and it can be challenging in other patients (those with ascites or Chilaiditi syndrome) [109]. Also, PTBD involves a nonphysiologic and uncomfortable external drainage, and its rate of complications is nearly 30 % including cholangitis, peritonitis, empyema, fistula, hematoma, peritoneal bleeding, and liver abscesses [110]. Surgical biliary drainage is rarely performed because of its high rates of morbidity (66 %) and mortality (32 %) in these often critically ill patients [111].

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The development of the linear EUS real-time puncture and the close proximity of the biliary system to the duodenum and gastric walls have extended the EUS applications. The first case series of EUS-guided cholangiography was reported by Wiersema et al. [112] in 1996. Later, Giovannini et al. [113] reported the first case of transluminal stenting. The EUS-BD procedure can be attempted by either an intra- or extrahepatic approach. The intrahepatic approach is performed below the level of the cardias at the lesser curvature of the stomach, with puncture of the left intrahepatic biliary system to access the biliary tract. In a few cases, the intrahepatic approach has been achieved by a transesophageal or transjejunal route. For the extrahepatic access to the biliary tract, the echoendoscope is positioned either in the duodenum or in the distal antrum depending on the anatomy of the patient, and the puncture site is at the upper/middle bile duct. In addition, three possible routes can be used for biliary drainage: transmural (hepaticogastrostomy [EUS-HG] and choledocoduodenostomy [EUSCD]), transpapillary anterograde, and transpapillary retrograde or rendezvous route. Consensus still has not been reached on whether the intra- or extrahepatic approach is preferable. When the two approaches are feasible, the intrahepatic access has been recommended by some authors as a safer option, mainly in terms of bile leakage [62]. However, other authors prefer the extrahepatic approach due to several limitations of the intrahepatic access. It is technically challenging because the nonapposition of the gastric wall and the left liver lobe increases the possibility of procedural failure and there is a risk of portal injury with small-caliber stents [69, 114]. No prospective study has compared the two approaches. As shown in the literature, the complication rates (14 vs. 18 %) and success rates (87 vs. 81 %) are very similar, with a slight trend in favor of the extrahepatic approach. Nevertheless, in clinical practice the choice between the two approaches is mainly conditioned by several factors, such as the level of the biliary obstruction, the impeded access to the duodenum, the presence of ascites, the insufficient dilation of the intrahepatic ducts, and the expertise of the operator. With regard to complications, the route of drainage seems to be more relevant than whether the intra- or extrahepatic approach is used. Most series have reported the results of EUS-BD in heterogeneous groups of patients who underwent rendezvous or transmural techniques of drainage. After the exclusion of patients from series whose adverse outcomes of the different drainage routes were not clearly differentiated, the complications of transmural drainage were twice as frequent as those after the rendezvous procedure (21 vs. 11 %, respectively). This is explained by noting that EUS-RV requires only needle

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puncture and temporary guidewire placement, whereas transmural drainage requires the creation and dilation of a biliary enteric fistula. This procedure can result in pneumoperitoneum and bile leakage. Although the risk of these two complications with EUS-RV is low, pneumoperitoneum and bile leakage have also been reported respectively in 1.5 and 2.5 % of EUS-RV procedures. Notably, the most frequent adverse outcome of EUS-RV is acute pancreatitis (31 % of complications), indicating that EUS-RV can cause complications resulting from either EUS-BD or ERCP. Other complications are both uncommon and mild. Although a safer route of drainage, EUS-RV is at least as challenging as transmural drainage. An accessible papilla or bilioenteric anastomosis is required, but this may be hampered by duodenal infiltration and a surgically altered anatomy. In addition, accessing the biliary tract with a wire is easy, but maneuvering the wire across the stricture may be difficult, and a successful passage of the guidewire into the small bowel is not always possible. This explains the comparatively lowest rate of technical success: 75 % for EUS-RV, 79 % for EUS-HG, and 85 %, for EUS-CD. The complication rates for EUS-HG (24 %) and EUSCD (19 %) are close. As noted earlier, the most frequent complications of transmural EUS-BD (bile leakage and pneumoperitoneum) are related to the required fistula between the digestive tract and the biliary system. Although EUS-HG has been largely considered as having a higher risk of bile leakage or pneumoperitoneum, this occurred in 7 and 6 % of both procedures respectively. Pneumoperitoneum was in most cases managed with conservative measures, and only one patient underwent surgery. The incidence of bleeding increased slightly in patients who had undergone EUS-HG (5 vs. 2 %). Bleeding usually arises from transmural instrumentation. During EUS-HG, the access from the cardias or the fundus requires an acute angulation of the echoendoscope, making the devices point tangentially, which can lead to an undesirable incision with a chance of bleeding. The frequency of infectious complication was comparable between the two techniques, and other complications were rare. From a technical point of view, the most relevant choices are the approach to dilation of the fistula and the type of stent. Once the biliary system has been accessed with a EUS fine-needle aspiration, two different approaches to dilation of the fistula are possible: a graded dilation using ERCP catheters, balloons, or bougie dilators and the use of cautery with a needleknife or a cystotome. The use of cautery is suggested to be a possible risk factor for bleeding and pneumoperitoneum. Evaluation of this issue is extremely difficult because most available studies in the literature have used both techniques in their series. One

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study conducted by Park et al. [67] found that the use of a needleknife for fistula dilation was the most significant risk factor for postprocedural complications (OR, 12.4; p = 0.01). The explanation argued by the authors was again the tangential approach of the catheter from the gastric or duodenal positions at risk for pneumoperitoneum and bleeding. Therefore, some authors advocate the use of cautery only after mechanical dilation has failed [67, 115]. However, graded dilation may fail due to the curved position of the endoscope that impairs the transmission of the pushing force, and it is rarely feasible for EUS-CD due to the fibrous wall of the common bile duct. Accordingly, the location of fistula dilation (gastric body for EUS-HG vs duodenum for EUS-CD) was a predictive factor for successful graded dilation (OR, 0.062; p \ 0.0001). Although no studies comparing plastic or SEMS exist for conclusions to be drawn, SEMS provides several advantages over plastic stents. The larger diameter is expected to provide longer-lasting patency, thus minimizing the risk of stent occlusion, and the management of stent occlusion may be less challenging because a new stent can easily be introduced through the occluded stent. A covered SEMS, when fully expanded, is superior to a plastic stent in sealing the fistula and thus preventing bile leakage. However, in the only study evaluating risk factors for postprocedural complications, the type of transluminal stent did not affect the rate of adverse events [67]. Uncovered SEMS (UC-SEMS) should not be used due to the high risk of bile leakage, and the use of partially covered SEMS (PC-SEMS) was discouraged after findings showed a higher risk of bile leakage associated with stent foreshortening after their placement in three patients, one of them with fatal consequences [63, 83, 116]. Fully covered SEMS (FC-SMES) are appealing because they immediately seal the dilated fistulous tract, but fears exist about the risk of migration because five cases of stent migration have been reported with FC-SMES [67, 69, 71]. To avoid proximal stent migration, at least 1.5 cm of the distal stent end in the lumen of the gut must be secured. Also, puncture of a dilated bile duct in segment 3 of the liver is recommended when EUS-HG is attempted. Proceeding in this way, the puncture is performed at the level of the lesser curve. From this position, the tip of the stent is easily checked during its deployment. However, the puncture of a dilated bile duct in segment 2 from the cardias hampers visualization of the stent deployment and thus increases the risk of stent migration. Future developments should enable the availability of stents providing lumen-to-lumen anchorage. Meanwhile, the recommended strategy for reducing the risk of bile leakage and pneumoperitoneum with metal stents in patients with malignant strictures is to combine an UCSEMS with a FC-SEMS. The former is deployed initially

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to provide anchorage and prevent migration, and the latter is introduced coaxially and deployed within the first to prevent bile leakage. For patients with benign conditions, the alternatives are a FC-SEMS with flared ends, insertion of a double-pigtail stent through the expanded SEMS, and forceful balloon expansion of the stent. When a plastic stent is the selected option in the absence of a SEMS, a double-pigtail stent should be inserted to prevent stent migration. To date, patients with failed ERCP have been referred for either surgical intervention or PTBD, but EUS-BD currently is an attractive alternative after failed ERCP, with the additional advantage that it can be performed during the same sedation as that for attempted ERCP. Artifon et al. [79] found EUS-BD and PTBD to have similar efficacy and complications. The complication rate tended to be higher in the PTBD group (25 vs. 15 %; p = 0.44), but the number of patients was too small for this difference to be statistically significant. The indications and the optimal timing for EUS-BD have not been established. Currently, the standard of care after a failed ERCP remains PTBD. Although EUS-BD may offer an effective alternative, larger comparative studies are needed before it can be decided whether to proceed directly with EUS-BD after a failed ERCP or PTBD. The EUS-BD procedure is a complex technique that requires an experienced endoscopist skilled in both EUS and ERCP. Proper selection of patients is also of great importance. The EUS-RV procedure may rightly be considered after a failed cannulation in patients with benign causes of biliary obstruction because it is less invasive and tract dilation is not required. However, EUS-CD and EUSHG are more appropriate for palliative drainage in cases of malignant obstruction because the object of transmural stenting is to provide a permanent biliary diversion. Prospective randomized trials are needed to decide which of the following are safer: transgastric or transduodenal approach, transmural or rendezvous drainage, graded dilation with balloons and tapered dilators or use of electrocautery, and plastic or metal stents. EUS-guided pancreatic duct drainage (EUS-PD) Epigastric pain associated with several pancreatic conditions, such as chronic pancreatitis and stenotic pancreaticoenterostomy, is caused mainly by pancreatic ductal hypertension. Endoscopic decompression by ERCP currently is offered to relieve pain. However, the success rate for endoscopic intervention varies widely (30–100 %) due to factors such as a difficult cannulation, a tight stenosis, or an inaccessible pancreatic duct because of a duodenal stenosis or a surgically altered anatomy.

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Surgery is the only alternative for pancreatic duct decompression after a failed ERCP. The main advantage is that surgery allows both ductal decompression and partial resection when required, but at the expense of a high morbidity rate, with approximately 20 % of patients experiencing persistent pain and up to 10 % experiencing new-onset pain due to inadequate drainage or anastomotic strictures [117–119]. The EUS-PD procedure was first reported in 2002 by Bataille and Deprez as an alternative to surgery after ERCP failure. Drainage of the main pancreatic duct guided by EUS can be achieved during a rendezvous procedure using placement of a retrograde stent or a transluminal approach (via the stomach-pancreaticogastrostomy or the duodenumpancreaticobulbostomy) when the level of the duct obstruction cannot be traversed or the papilla is not accessible. Currently, it is not possible to conclude which of the two approaches is superior due to the sparse data available. As for EUS-BD, studies favoring the rendezvous procedure showed the lowest rates of complications. Therefore, achieving transpapillary or transanastomotic drainage by the rendezvous technique may seem to be more attractive, but its limitations are the same as for biliary drainage: the papilla or the surgical anastomoses have to be accessible, and the advancement of the guidewire is rarely possible due to very tight strictures or complete obstruction. This explains the low rate of success reported by some authors (average rate in pooled analysis, 42 %; range, 25–64 %) [82, 88–90]. Taking the transmural and rendezvous procedures together, the rates of procedural complications vary between 7 and 46 % (average, 16 %) when the stent dysfunction is excluded. However, stent dysfunction has been reported by some authors as the most frequent adverse outcome, observed in 50–100 % of cases [85, 87, 89] and requiring repeated procedures for stent exchange. The obstruction probably is related to the small caliber of the drainage stents used. Migration might be favored by the limited intraductal length of the stent and the strong propulsive contractions over the intragastric portion. Nevertheless, stent exchange is not always possible (if the main pancreatic duct is no longer dilated) or not necessary (in patients remaining asymptomatic after a previous successful drainage) [87]. To prevent complications, the first and most important issue is the appropriate selection of patients. Patients with a high risk for surgery probably are the ones to be considered first. Surgery for patients with an inflammatory retroperitoneum is quite invasive, and this procedure could be used as a bridge to surgery for patients with intractable pain. Patients who have already had pancreatic surgery and are experiencing anastomotic stricture-related symptoms are

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also suitable candidates. One observation to keep in mind, although not considered to be a procedure-related complication, is the high incidence of pancreatic cancer observed during the follow-up period in two series. Thus, cancer must be clearly eliminated before the decision to use EUSPD, and the possibility of a missed tumor must be taken into consideration if the patient has no symptoms relief or experiences recurrence after EUS-PD. The technical aspects of EUS-PD have been emphasized by some authors [89]. Care should be taken to limit the volume and concentration of the contrast injected, which may reduce the risk of pancreatitis and help to maintain visualization of targeted areas. Adequate echoendoscope placement is also important because a perpendicular orientation between the endoscope and the pancreatic duct makes the inadvertent pass of the guidewire into a side branch more likely. The most suitable stents should have a small diameter, sufficient length and side flaps to avoid intrapancreatic migration, and no lateral holes to prevent leakage in the perigastric space. Moreover, they must be straight stents rather than pigtail stents to facilitate insertion and placement into the duct and to prevent expulsion by gastric motility. In some cases, to decrease the perforation risk, it is also advisable to wait 2–4 weeks, when a completed fistula tract is formed, before trying the passage of different devices through the stricture. The question of which stents are optimal for reducing the dysfunction rate remains unanswered. The creation of a larger fistula is limited by the size of the pancreatic duct, and previous experience with the placement of multiple stents in a short pancreatic duct has shown an increased risk of stent migration [89]. In conclusion, EUS-guided therapeutic procedures are feasible and often a more suitable alternative to radiologic and surgical interventions. This is true in the case of EUSguided drainage of PFCs and EUS-guided celiac plexus interventions, for which current data, although limited, suggests outcomes comparable with those of surgery and radiologic procedures, with fewer complications. However, compared with diagnostic EUS and EUS-guided fine-needle biopsy, the risk of complications is considerably higher for EUS-guided therapeutic interventions [1, 2, 120]. This is especially true for pancreaticobiliary drainage, in which severe complications are not uncommon. Moreover, due to methodologic limitations in current reports, several questions remain before EUS-guided pancreatobiliary drainage can be broadly advocated as a firstline treatment after a failed ERCP. Therapeutic EUS procedures are technically demanding and require experienced therapeutic endoscopists. Indications must be clearly stated, and patients must be carefully selected. Well-designed prospective trials in homogeneous populations must be

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conducted to define the risks and long-term outcomes accurately, to standardize the techniques, and to clarify their role and appropriate timing. Finally, the future development of dedicated devices is likely to reduce the number of adverse events. Disclosures Marıá-Victoria Alvarez-Sańchez, Christian Jenssen, Siegbert Faiss, and Bertrand Napoleón have no conflicts of interest or financial ties to disclose.

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Interventional endoscopic ultrasonography.

Stoma complications: an overview.

Potential application of interventional endoscopic ultrasonography for the treatment of esophageal and gastric varices.

Depression and postoperative complications: an overview.

Observational and interventional study design types; an overview.

Endoscopic ultrasonography.

Endoscopic ultrasonography.

Dextromethorphan. An overview of safety issues.

Safety and utility of single-session endoscopic ultrasonography and endoscopic retrograde cholangiopancreatography for the evaluation of pancreatobiliary diseases.

Uncommon complications of therapeutic endoscopic ultrasonography: What, why, and how to prevent.

Therapeutic endoscopic ultrasonography.

Endoscopic ultrasound guided interventional procedures.

Clinical safety and tolerance of cefoxitin sodium: an overview.

Cilazapril: an overview of its efficacy and safety in hypertension.

The safety and tolerability of sumatriptan: an overview.

Endoscopic management of bleeding gastric varices--an updated overview.

Endoscopic treatment of iatrogenic gastrointestinal perforations: an overview.

An Overview of Endoscopic Ultrasound-Guided Gastroenteric Anastomosis.

Endoscopic ultrasonography in gastrointestinal cancer.

Overview of fluoroquinolone safety.

Endoscopic ultrasonography in colorectal diseases.

Overview of safety pharmacology.

An overview of breast emergencies and guide to management by interventional radiologists.

Endoscopic sphincterotomy complications and their management: an attempt at consensus.