ORIGINAL ARTICLE
Endoscopic gallbladder drainage compared with percutaneous drainage Prashant Kedia, MD, Reem Z. Sharaiha, MD, MSc, Nikhil A. Kumta, MD, Jessica Widmer, DO, Armeen Jamal-Kabani, FNP-BC, Kristen Weaver, RN, Andrea Benvenuto, NP, Jennifer Millman, RN, Rahul Barve, MD, Monica Gaidhane, MD, MPH, Michel Kahaleh, MD New York, New York, USA
Background: High-risk patients with cholecystitis have conventionally been offered percutaneous gallbladder drainage (PGBD) for treatment. A growing experience of endoscopic gallbladder drainage (EGBD) has been reported to be effective and safe. Objective: To compare the short- and long-term outcomes of EGBD and PGBD. Design: A retrospective review. Setting: Single academic tertiary care center. Patients: Inpatients diagnosed with cholecystitis. Interventions: Any patient deemed a nonsurgical candidate and who has undergone either PGBD or EGBD was included in the analysis. Main Outcome Measurements: Patient demographics along with procedural and clinical outcomes were recorded for each group. Results: Forty-three patients underwent PGBD and 30 underwent EGBD (24 transpapillary, 6 transmural). Technical (97.6% vs 100%) and clinical (97.6% vs 86.7%) success rates of PGBD and EGBD were similar. However, postprocedure hospital length of stay (16.3 vs 7.6 days), time to clinical resolution (4.6 vs 3.0 days), adverse event rate (39.5% vs 13.3%), number of sessions (2.0 vs 1.0), number of repeat interventions (53.4% vs 13.3%), and postprocedure pain scores (3.8 vs 2.1) were significantly higher for PGBD than EGBD. Limitations: Retrospective analysis. Conclusion: Although EGBD has similar technical and clinical success compared with PGBD, it uses fewer hospital resources and results in fewer adverse events, improved pain scores, and decreased need for repeat gallbladder drainage. EGBD may provide a less-invasive, safer, cost-effective option for gallbladder drainage than PGBD with improved clinical outcomes. (Gastrointest Endosc 2015;-:1-6.)
As the general population continues to age, an increasing number of patients with comorbidities who are poor surgical candidates will require management of cholecystitis. The
conventional treatment for this select group of patients has been percutaneous gallbladder drainage (PGBD) via cholecystostomy tube placement. Although the technical success
Abbreviations: EGBD, endoscopic gallbladder drainage; PGBD, percutaneous gallbladder drainage.
0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2015.03.1912
DISCLOSURE: The following author disclosed financial relationships relevant to this publication: M. Kahaleh: Consultant for Boston Scientific and Xlumena; Research grants from Boston Scientific, Fuji, Pentax, MI Tech, EMcision, ASPIRE Bariatrics, GI Dynamics, W.L. Gore Associates, Cook Endoscopy, Apollo Endosurgery, and MaunaKea Tech. All other authors disclosed no financial relationships relevant to this publication.
Received October 9, 2014. Accepted March 5, 2015.
Copyright ª 2015 by the American Society for Gastrointestinal Endoscopy
www.giejournal.org
Current affiliations: Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, New York, USA. Presented at Digestive Disease Week, May 3-6, 2014, Chicago, Illinois. Reprint requests: Michel Kahaleh, MD, AGAF, Chief, Endoscopy, Professor of Medicine, Division of Gastroenterology & Hepatology, Weill Cornell Medical College, 1305 York Avenue, 4th Floor, New York, NY 10021.
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rate of this technique is approximately 97% to 98%, it carries significant risk of adverse events.1-3 The adverse event risk associated with PGBD is reported to be as high as 14%, including pneumothorax, bile leak, subcapsular hematoma, pain, and catheter misplaced/migration.1,3,4 Also, PGBD is a nonphysiologic form of bile drainage that can result in alterations of bile acid homeostasis. By draining bile outside of the body, increased stress is put on the liver to maintain the bile acid pool, which is on average 2 to 4 g.5 Finally, PGBD may be contraindicated in cases of thrombocytopenia, coagulopathy, large peritoneal ascites, and Chilaiditi syndrome.6 For these reasons, less-invasive forms of endoscopic gallbladder drainage (EGBD) have been developed. The first case of EGBD was reported by Kozarek in 1984.7 Since that time, 2 primary methods of EGBD have been described, including transpapillary and transmural stenting. Transpapillary and transmural naso-gallbladder catheter placement have also been described but are less well tolerated and less successful.2 Transpapillary drainage can only provide drainage via the cystic duct with a maximum diameter of 10F, not permitting any major drainage such as that which a 30F transduodenal stent can offer. Thus, for our purposes, transpapillary drainage refers to performing ERCP to access the gallbladder lumen through the cystic duct with a wire and place a transpapillary, transcystic double-pigtail plastic stent usually 7F to 10F in caliber (Fig. 1). Although individual case series of the technical success rates of this method vary, a systematic review revealed pooled success and adverse event rates of 96% and 6.3%, respectively, for transpapillary EGBD.2,6,8 The second form of EGBD, transmural drainage, uses EUS to puncture the gallbladder from a transgastric or transduodenal position (Fig. 2) and directly place a plastic or fully covered metal stent into the lumen of the gallbladder with the opposite flange terminating in either the antrum or duodenal bulb (Fig. 3). Various case series describing both plastic and metal stent placement via transmural EGBD quote technical success rates of 100%.8-11 A recent systematic review reported pooled success and significant adverse event rates of 96.7% and 5.5%, respectively, for transmural EGBD in 90 cases.12 Although both routes of EGBD have been shown to be highly successful with minimal adverse events, the role of EGBD in the management algorithm of cholecystitis has not been confirmed because of a paucity of comparative data with percutaneous drainage. The only comparative study in the literature is a randomized controlled trial evaluating 30 and 29 patients having undergone endoscopic naso-gallbladder drainage or PGBD, respectively.13 Both groups had similar technical success, clinical success, and adverse event rates, but the endoscopic groups had lower postprocedure pain scores. Thus, EGBD may offer poor surgical candidates a less-invasive, equally successful, and less-morbid option for gallbladder drainage than 2 GASTROINTESTINAL ENDOSCOPY Volume
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Figure 1. Deployment of a 7F 15-cm double-pigtail plastic stent into the gallbladder from the transpapillary position.
PGBD. This study retrospectively compares outcomes in a series of 73 patients having undergone EGBD or PGBD at a single academic tertiary care center.
METHODS The study was approved by the institutional review board of Weill Cornell Medical College. The charts of inpatients from July 2011 through November 2013 with an inpatient ICD-9 code for a diagnosis of cholecystitis at a single academic tertiary care center were reviewed retrospectively. Any patient deemed not to be a surgical candidate and thus requiring minimally invasive drainage (PGBD or EGBD) was included in the analysis. Patient demographics along with procedural and clinical outcomes were recorded for each group.
Outcome variables Patient demographic variables, including age and sex, were recorded. All patients underwent a radiographic study (abdominal US or CT ) to distinguish the type of cholecystitis (calculous vs acalculous). Details regarding each patient’s hospitalization, including length of stay, date of procedure, and length of stay after the procedure, were recorded. All patients underwent either EGBD or PGBD, and their data were analyzed in the group of their initial intervention for cholecystitis. Details of the intervention, including type (PGBD vs EGBD), number of sessions, and technical success, were detailed. Endoscopic drainage was performed by 1 of 2 routes of drainage (transpapillary vs transmural). The clinical outcomes and hospital course variables were included, such as clinical resolution of cholecystitis, time to clinical resolution, postprocedure pain, and adverse events. The long-term clinical outcomes www.giejournal.org
Kedia et al
Endoscopic vs percutaneous gallbladder drainage
Figure 2. Endosonographic-guided puncture of the gallbladder with a 19-gauge EUS-FNA needle.
regarding adverse events, need for repeat intervention, and length of follow-up were recorded.
Definitions Although all patients included in the analysis had an ICD-9 code for cholecystitis, their charts were reviewed to ensure they met the Tokyo guidelines for cholecystitis, which included a constellation of classic symptoms (right upper quadrant pain, fever, leukocytosis) along with correlating radiographic findings (abdominal US or CT scan).14 Patients were stratified into calculous versus acalculous cholecystitis by the findings on their radiographic study. Technical success was defined as the ability to place a drainage catheter or stent into the gallbladder whether it was by the percutaneous or endoscopic route. Clinical success was defined by improvement in the patient’s overall clinical picture in terms of fevers, leukocytosis, pain, and ability to tolerate oral intake. Immediate and 7-day postprocedure adverse events were recorded. Ward nurses recorded patients’ pain levels on every shift change using a visual analog scale. The highest pain score within 1 day after the procedure was designated as the postprocedure pain score. Any procedure required to place, maintain, or remove a drainage device (stent, catheter) was considered a procedural session. Any patient who underwent further gallbladder intervention (surgical, PGBD, or EGBD) because of persistent symptoms of cholecystitis from inadequate drainage from the initial procedure or recurrence of symptoms because of loss of efficacy from the initial procedure was included in the reintervention group.
Procedure technique PGBD was performed by expert interventional radiologists at our tertiary care center using intravenous conscious www.giejournal.org
Figure 3. Deployment of a transmural fully covered metal stent into the gallbladder with expression of pus.
sedation. The procedures were performed in the interventional radiology suite using sterile technique, and either 8F or 10F catheters (All Purpose Drainage Catheter; Boston Scientific, Natick, Mass) were placed. Patients were routinely brought back after 6 to 8 weeks for catheter check under fluoroscopy and removal. All EGBDs were performed by 2 expert biliary endoscopists (M.K., R.Z.S.), either in the endoscopy suite or the operating room depending on the stability of the patient. Endoscopic drainage was performed in either a transpapillary or transmural approach. Transpapillary drainage was always the first choice for gallbladder drainage before converting to transmural drainage. To perform transpapillary drainage, biliary cannulation was performed with a standard duodenoscope (TGF-Q180V; Olympus, Center Valley, Pa). Using various catheters (Autotome Rx; Boston Scientific, and Swing Tip; Olympus) and wires (Hydra Jagwire; Boston Scientific, and Glidewire; Terumo, Somerset, NJ), they obtained access to the gallbladder through the cystic duct. The wire was coiled deep into the gallbladder fossa. The cystic duct was subsequently dilated with 6F to 8F dilators (Soehendra; Cook Medical, Winston-Salem, NC) over the wire. Then either a 5F or 7F tapered plastic double-pigtail stent (Zimmon; Cook Medical) was inserted over the wire and deployed with 1 pigtail in the gallbladder fossa and the other across the ampulla into the duodenal lumen. Endoscopic sphincterotomy was performed in all transpapillary stent placements. If transpapillary drainage was not possible because of cystic duct obstruction or tortuosity, then transmural drainage was performed. To do this, a linear echoendoscope Volume
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(GF-UCT180; Olympus) was used to identify the gallbladder from the gastric antrum or duodenal bulb by endosonography. Every attempt was made to access the gallbladder from the transduodenal position if possible. After checking local vasculature with color-flow Doppler, the gallbladder was punctured with a 19-gauge needle (ECHO-19; Cook Medical). Bile aspiration of the needle confirmed position within the gallbladder and was sent for culture. Subsequently a .035-inch wire (Hydra Jagwire; Boston Scientific) was advanced through the needle and coiled in the gallbladder. Then, the tract was dilated over the wire with a 4-mm 4-cm dilating balloon (Hurricane; Boston Scientific). Subsequently, either a 10-mm 6-cm or 10-mm 8-cm fully covered metal biliary stent (VIABIL; W.L. Gore Associates, Utica, NY) was deployed into the gallbladder fossa to create either a cholecystoduodenostomy or cholecystogastrostomy. To prevent migration, a 10F double-pigtail plastic stent (Boston Scientific) was deployed through the metal transmural gallbladder stent.
Statistical analysis The c2 test or Fisher exact test was used for categorical variables and t test for continuous variables. P % .05 was considered significant. All statistical analysis was performed by using STATA 13.0 (StataCorp, College Station, Tex). All authors had access to the study data and reviewed and approved the final manuscript.
RESULTS Between 2011 and 2013, 1355 inpatients had a diagnosis code of cholecystitis at our institution. Seventy-three patients (5.4%) were deemed unfit surgical candidates and underwent gallbladder drainage. The mean ages for PGBD and EGBD patients were 66.9 18.0 and 62.5 18.3, respectively. Among patients who underwent drainage of symptomatic cholecystitis, 30 (41.1%) were treated with endoscopic drainage (24 transpapillary, 6 transmural) and 43 (58.9%) with percutaneous drainage. The mean duration of follow-up for the cohort of patients in this study was 9.4 months (percutaneous drainage) and 8.8 months (endoscopic drainage), P Z .38. There were no significant differences between the groups with regard to demographics, concomitant choledocholithiasis, and baseline severity index (Table 1). All patients with choledocholithiasis underwent biliary decompression via ERCP. There was no significant difference in the etiology of cholecystitis between the 2 groups. There was a significant difference in the use of general anesthesia between the 2 groups because it was used in all endoscopic procedures and only 16.7% of the percutaneous procedures. There was no difference in technical success between EGBD (100%) and PGBD (97.6%), P Z .58. There was no difference between clinical resolution between the 4 GASTROINTESTINAL ENDOSCOPY Volume
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TABLE 1. Demographic and baseline clinical variables P value
Endoscopy
PGBD
Age, y
62.5 18.3
66.9 18.0
.15
Sex (M)
14
23
.23
Underlying pathology Calculous
16
29
Acalculous
14
14
Total follow-up time
8.9 7.3
9.4 8.4
.39
Concomitant choledocholithiasis
13 (43.3%)
9 (20.1%)
.068
Mean Charlson Comorbidity Index
6.1
5.6
.47
100%
16.3%
.0001
General anesthesia
PGBD, Percutaneous gallbladder drainage.
PGBD and EGBD groups: 97.6% versus 87%; P Z .08. The mean time to clinical resolution was significantly higher in the percutaneous group, at 4.6 days, versus the endoscopic group, at 2.95 days, P Z .05. The mean number of sessions for the PGBD and EGBD was 2.0 versus 1.06, P ! .0001. The mean postprocedure pain score was 2.1 for the endoscopic group and 3.8 for the percutaneous group, P Z .028. The reintervention rate was significantly higher in the percutaneous drainage group compared with the endoscopic drainage group (53% vs 13%; P Z .004) (Table 2). The median number of adverse events was significantly higher for the PGBD group than for the EGBD group (17 vs 4, P Z .013). There were no differences in the rates of early adverse events (5 vs 4) between PGBD and EGBD, P Z .55. Adverse events in the EGBD group included sphincterotomy bleeding (2), worsening cholecystitis (1), and stent migration (1). Adverse events in the PGBD included catheter dislodgment (6), catheter migration (2), catheterrelated pain (1), catheter occlusion (1), cellulitis (1), perihepatic abscess (1), intraperitoneal bleeding (1), cholecystitis (1), cholangitis (1), myocardial infarction (1), and mechanical fail during procedure (1). Significantly more late adverse events (12 vs 0) occurred in the PGBD group, P ! .0001. Patients undergoing PGBD had a significantly longer length of hospital stay (16.3 vs 7.6 days, P Z .04). Subgroup analysis comparing outcomes between the patients who underwent transpapillary endoscopic drainage (n Z 24) versus PGBD was similar to the overall comparison. There was no difference in clinical success between the 2 groups (P Z .127), whereas transpapillary endoscopic drainage had fewer adverse events (P Z .046) and a shorter time to clinical resolution (P Z .015).
DISCUSSION As the population continues to age, less-invasive means of managing cholecystitis in high-risk patients will be www.giejournal.org
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TABLE 2. Procedural and clinical outcomes P value
EGBD
PGBD
Technical success
100%
97.6%
.58
Clinical success
26/30
42/43
.08
Number of sessions
1.0
2 (1-5)
.000
Time to clinical success, days
2.95
4.6
.05
4
17
.013
Adverse events Early
4
5
.55
Late
0
12
!.0001
2.1
3.8
.028
4
23
.001
7.6
16.3
.046
Postprocedural pain No. of subjects with repeat interventions Length of stay postprocedure, days
EGBD, Endoscopic gallbladder drainage; PGBD, percutaneous gallbladder drainage.
needed given the mortality risk of 30% with surgery in this population.15 With the increasing intraductal precision of ERCP and the advent of interventional EUS, endoscopic drainage of the gallbladder is not only feasible but also safe. However, because of the longstanding convention of using PGBD, the general medical community has not yet recognized or clarified the role of EGBD in the management algorithm of high-risk cholecystitis. Although PGBD is effective, generally safe, and relatively convenient in morbid patients, it is significantly limited by its nonphysiologic drainage of the biliary system and long-term catheter-related adverse events. EGBD offers a less-invasive solution to both of these issues. Limited studies have compared these 2 modalities. Our study is the largest comparison of these 2 techniques in a nonsurgical population with cholecystitis. Although this was a retrospective analysis, both populations in this study were of similar age, gender, and baseline clinical severity and had a similar length of follow-up. In addition, all patients were poor surgical candidates because of comorbidities. Of all variables analyzed, PGBD and EGBD were similar only in their technical and clinical success rates. Although the rate was not statistically significant, we attribute the slightly lower clinical success rate of EGBD as compared with PGBD to the small sample size of the study. We performed a subgroup analysis comparing the transpapillary endoscopic drainage versus PGBD because most endoscopic patients were drained via this method. There were not enough patients to perform subgroup analysis for the transmural endoscopic drainage group. The transpapillary subgroup analysis yielded similar comparative results with the overall analysis. This implies that the small number of transmural patients was not the underlying reason for more favorable outcomes in the overall EGBD group compared with PGBD. In all other categories, EGBD was superior to PGBD in terms of efficiency, safety, tolerability, and long-term efficacy. From a fiscal and logistical standpoint, EGBD requires www.giejournal.org
fewer sessions than PGBD for completion of therapy and also is associated with a significantly shorter postprocedure length of hospitalization. Because EGBD via transpapillary or transmural stent placement can be a definitive treatment, not requiring removal or revision, it is expected to have fewer sessions than PGBD. Percutaneous drains are generally removed after 6 to 8 weeks of placement for patient comfort and to reduce the risk of infection and fistula formation. Thus, PGBD requires at least 2 sessions for completion of therapy. However, frequently more than 2 sessions are required because of catheter clogging or migration. In our study, 32.5% of PGBD procedures required more than 2 sessions before completion of therapy. In addition, the postprocedure length of stay was significantly shorter for EGBD than PGBD. This may be because of a significantly shorter time to clinical resolution of disease in EGBD patients compared with PGBD. The reason for this is not clear because the baseline clinical severity of both groups was similar. However, it may be related to the caliber of the stent used for drainage. Another reason is that patients may need a longer period to adjust to their percutaneous catheters and to the higher pain associated with them before feeling comfortable leaving the hospital. A previous randomized controlled trial has shown that endoscopic therapy results in lower pain scores for patients compared with percutaneous modalities. Our study confirmed this notion, with the pain score for EGBD being almost 50% lower than PGBD 1 day after the procedure. EGBD may avoid the psychosomatic issues that result from external catheter drainage. Minimizing the number of sessions required for therapeutic completion along with the postprocedure pain and days of hospitalization may result in significant cost savings and improved quality of life for the patient. Because the mean follow-up period for both groups was on the order of about 9 months, the long-term adverse events of both techniques could be assessed. PGBD had significantly more long-term adverse events, most of which were catheter-related, compared with EGBD. The most common of these was catheter dislodgement, resulting in either dysfunction or complete removal of the device, thus requiring repeat intervention in many cases. In only 1 EGBD case was there concern for stent migration, which was recognized acutely and revised soon after the procedure. Most EGBD-related adverse events were related to the risk of ERCP itself, which included sphincterotomyrelated bleeding and postprocedure pancreatitis. In our series, 2 patients required repeat intervention for sphincterotomy bleeding, and none endured post-ERCP pancreatitis. Although these are some of the adverse events specific to EGBD and not PGBD, we expect them to mitigate with the increased performance of EUS-guided transmural EGBD. Some adverse events specific to PGBD include pneumothorax and hemobilia. Adverse events common to both Volume
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techniques include pneumoperitoneum and bile leak. Although pneumoperitoneum is expected in both procedures, it is rarely a clinically significant adverse event. Bile leak and subsequent peritonitis, on the other hand, are significant and must be avoided. Only 1 case of bile peritonitis has been reported in the transmural EGBD literature.9 With the approval and availability of new fully covered lumen-apposing metal stents, this risk may also be abated.10,16,17 Although the technical and clinical success rates of the 2 techniques were similar in the short term, the long-term efficacy is an issue of great clinical and economic importance. There are limited data on the long-term viability of EGBD because of its recent inception; however, early data are encouraging. One study reported an absence of recurrence of cholecystitis in 93.5% after EGBD in up to 5 years of follow-up.18 Another prospective multicenter study of 29 patients having undergone transpapillary EGBD reported a 2-year patency rate of 80%.19 This is compared with the reported cumulative recurrent cholecystitis rate of 33% 2 years after percutaneous drain removal. Another study reported a 22% recurrence of cholecystitis at a median of 151 days after catheter removal.4 In our study, both groups had a similar follow-up range. The PGBD arm had almost 6 times as many reinterventions for gallbladder drainage than the EGBD group either because of inadequate drainage from the existing catheter, catheter migration, or ongoing symptoms of cholecystitis. A comparison of the long-term efficacy of these 2 techniques has never been reported. We believe that because of the instability of the percutaneous catheter position over time related to regular “wear and tear” along with an increased likelihood for physical tampering, its longterm efficacy compared with EGBD is significantly inferior. This concept needs further study to confirm these findings but could have significant implications on the superiority of 1 technique over the other in terms of being a definitive therapy. We recognize that the retrospective nature and relatively small sample size are limitations of this study. However, this is the largest comparison of EGBD and PGBD published to date, reporting not only short-term but also long-term clinical variables related to treatment of cholecystitis. Although EGBD has similar rates of immediate clinical and technical success as PGBD, it is associated with utilization of fewer inpatient resources, fewer adverse events, lower pain scores, quicker clinical response, and a decreased need for repeat gallbladder intervention. EGBD may provide a less-invasive, less-painful, safer, and more cost-effective option for gallbladder drainage than PGBD in the short- and long-term outlook in cholecystitis management. Further prospective comparative studies are needed to decide its role in the management algorithm of high-risk patients with this disease.
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REFERENCES 1. Chopra S, Dodd GD 3rd, Mumbower AL, et al. Treatment of acute cholecystitis in non-critically ill patients at high surgical risk: comparison of clinical outcomes after gallbladder aspiration and after percutaneous cholecystostomy. AJR Am J Roentgenol 2001;176:1025-31. 2. Itoi T, Coelho-Prabhu N, Baron TH. Endoscopic gallbladder drainage for management of acute cholecystitis. Gastrointest Endosc 2010;71: 1038-45. 3. Winbladh A, Gullstrand P, Svanvik J, et al. Systematic review of cholecystostomy as a treatment option in acute cholecystitis. HPB (Oxford) 2009;11:183-93. 4. Sanjay P, Mittapalli D, Marioud A, et al. Clinical outcomes of a percutaneous cholecystostomy for acute cholecystitis: a multicentre analysis. HPB (Oxford) 2013;15:511-6. 5. Dawson PA. Bile secretion and the enterohepatic circulation of bile acids. In: Feldman M, Friedman LS, Sleisenger MH, eds. Sleisenger and Fordtran’s gastrointestinal and liver disease, 7th ed, Vol 1. Philadelphia, PA: Saunders; 2002. p. 1055. 6. Itoi T, Sofuni A, Itokawa F, et al. Endoscopic transpapillary gallbladder drainage in patients with acute cholecystitis in whom percutaneous transhepatic approach is contraindicated or anatomically impossible (with video). Gastrointest Endosc 2008;68:455-60. 7. Kozarek. Selective cannulation of the cystic duct at time of ERCP. J Clin Gastroenterol 1984;6:37-40. 8. Hasan MK, Itoi T, Varadarajulu S. Endoscopic management of acute cholecystitis. Gastrointest Endosc Clin North Am 2013;23:453-9. 9. Song TJ, Park DH, Eum JB, et al. EUS-guided cholecystoenterostomy with single-step placement of a 7F double-pigtail plastic stent in patients who are unsuitable for cholecystectomy: a pilot study (with video). Gastrointest Endosc 2010;71:634-40. 10. Itoi T, Binmoeller KF, Shah J, et al. Clinical evaluation of a novel lumenapposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos). Gastrointest Endosc 2012;75:870-6. 11. Jang JW, Lee SS, Park DH, et al. Feasibility and safety of EUS-guided transgastric/transduodenal gallbladder drainage with single-step placement of a modified covered self-expandable metal stent in patients unsuitable for cholecystectomy. Gastrointest Endosc 2011;74: 176-81. 12. Widmer J, Singhal S, Gaidhane M, et al. Endoscopic ultrasound-guided endoluminal drainage of the gallbladder. Dig Endosc 2014;26:525-31. 13. Jang JW, Lee SS, Song TJ, et al. Endoscopic ultrasound-guided transmural and percutaneous transhepatic gallbladder drainage are comparable for acute cholecystitis. Gastroenterology 2012;142: 805-11. 14. Hirota M, Takada T, Kawarada Y, et al. Diagnostic criteria and severity assessment of acute cholecystitis: Tokyo guidelines. J Hepatobil Pancreat Surg 2007;14:78-82. 15. Frazee R, Nagorney D, Mucha PJ. Acute acalculous cholecystitis. Mayo Clin Proc 1986;64:163-7. 16. Mönkemüller K, Zabielski M, Didowacz-Grollmann A, et al. Endoluminal transgastric endoscopic anastomosis of the gallbladder using an anchoring self-expanding metal stent. Endoscopy 2013;45(Suppl 2): E164-6. 17. Kedia P, Boumitri C, Sharaiha RZ, et al. Conversion of a percutaneous cholecystotomy tube into an internal cholecystogastrostomy using a novel anastomotic stent. Gastrointest Endosc 2014;81:228-9. 18. Maekawa S, Nomura R, Murase T, et al. Endoscopic gallbladder stenting for acute cholecystitis: a retrospective study of 46 elderly patients aged 65 years or older. BMC Gastroenterol 2013;13:65. 19. Lee TH, Park DH, Lee SS, et al. Outcomes of endoscopic transpapillary gallbladder stenting for symptomatic gallbladder diseases: a multicenter prospective follow-up study. Endoscopy 2011;43:702-8.
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Endoscopic gallbladder drainage compared with percutaneous drainage Prashant Kedia, MD, Reem Z. Sharaiha, MD, MSc, Nikhil A. Kumta, MD, Jessica Widmer, DO, Armeen Jamal-Kabani, FNP-BC, Kristen Weaver, RN, Andrea Benvenuto, NP, Jennifer Millman, RN, Rahul Barve, MD, Monica Gaidhane, MD, MPH, Michel Kahaleh, MD New York, New York, USA
Background: High-risk patients with cholecystitis have conventionally been offered percutaneous gallbladder drainage (PGBD) for treatment. A growing experience of endoscopic gallbladder drainage (EGBD) has been reported to be effective and safe. Objective: To compare the short- and long-term outcomes of EGBD and PGBD. Design: A retrospective review. Setting: Single academic tertiary care center. Patients: Inpatients diagnosed with cholecystitis. Interventions: Any patient deemed a nonsurgical candidate and who has undergone either PGBD or EGBD was included in the analysis. Main Outcome Measurements: Patient demographics along with procedural and clinical outcomes were recorded for each group. Results: Forty-three patients underwent PGBD and 30 underwent EGBD (24 transpapillary, 6 transmural). Technical (97.6% vs 100%) and clinical (97.6% vs 86.7%) success rates of PGBD and EGBD were similar. However, postprocedure hospital length of stay (16.3 vs 7.6 days), time to clinical resolution (4.6 vs 3.0 days), adverse event rate (39.5% vs 13.3%), number of sessions (2.0 vs 1.0), number of repeat interventions (53.4% vs 13.3%), and postprocedure pain scores (3.8 vs 2.1) were significantly higher for PGBD than EGBD. Limitations: Retrospective analysis. Conclusion: Although EGBD has similar technical and clinical success compared with PGBD, it uses fewer hospital resources and results in fewer adverse events, improved pain scores, and decreased need for repeat gallbladder drainage. EGBD may provide a less-invasive, safer, cost-effective option for gallbladder drainage than PGBD with improved clinical outcomes. (Gastrointest Endosc 2015;-:1-6.)
As the general population continues to age, an increasing number of patients with comorbidities who are poor surgical candidates will require management of cholecystitis. The
conventional treatment for this select group of patients has been percutaneous gallbladder drainage (PGBD) via cholecystostomy tube placement. Although the technical success
Abbreviations: EGBD, endoscopic gallbladder drainage; PGBD, percutaneous gallbladder drainage.
0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2015.03.1912
DISCLOSURE: The following author disclosed financial relationships relevant to this publication: M. Kahaleh: Consultant for Boston Scientific and Xlumena; Research grants from Boston Scientific, Fuji, Pentax, MI Tech, EMcision, ASPIRE Bariatrics, GI Dynamics, W.L. Gore Associates, Cook Endoscopy, Apollo Endosurgery, and MaunaKea Tech. All other authors disclosed no financial relationships relevant to this publication.
Received October 9, 2014. Accepted March 5, 2015.
Copyright ª 2015 by the American Society for Gastrointestinal Endoscopy
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Current affiliations: Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, New York, USA. Presented at Digestive Disease Week, May 3-6, 2014, Chicago, Illinois. Reprint requests: Michel Kahaleh, MD, AGAF, Chief, Endoscopy, Professor of Medicine, Division of Gastroenterology & Hepatology, Weill Cornell Medical College, 1305 York Avenue, 4th Floor, New York, NY 10021.
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rate of this technique is approximately 97% to 98%, it carries significant risk of adverse events.1-3 The adverse event risk associated with PGBD is reported to be as high as 14%, including pneumothorax, bile leak, subcapsular hematoma, pain, and catheter misplaced/migration.1,3,4 Also, PGBD is a nonphysiologic form of bile drainage that can result in alterations of bile acid homeostasis. By draining bile outside of the body, increased stress is put on the liver to maintain the bile acid pool, which is on average 2 to 4 g.5 Finally, PGBD may be contraindicated in cases of thrombocytopenia, coagulopathy, large peritoneal ascites, and Chilaiditi syndrome.6 For these reasons, less-invasive forms of endoscopic gallbladder drainage (EGBD) have been developed. The first case of EGBD was reported by Kozarek in 1984.7 Since that time, 2 primary methods of EGBD have been described, including transpapillary and transmural stenting. Transpapillary and transmural naso-gallbladder catheter placement have also been described but are less well tolerated and less successful.2 Transpapillary drainage can only provide drainage via the cystic duct with a maximum diameter of 10F, not permitting any major drainage such as that which a 30F transduodenal stent can offer. Thus, for our purposes, transpapillary drainage refers to performing ERCP to access the gallbladder lumen through the cystic duct with a wire and place a transpapillary, transcystic double-pigtail plastic stent usually 7F to 10F in caliber (Fig. 1). Although individual case series of the technical success rates of this method vary, a systematic review revealed pooled success and adverse event rates of 96% and 6.3%, respectively, for transpapillary EGBD.2,6,8 The second form of EGBD, transmural drainage, uses EUS to puncture the gallbladder from a transgastric or transduodenal position (Fig. 2) and directly place a plastic or fully covered metal stent into the lumen of the gallbladder with the opposite flange terminating in either the antrum or duodenal bulb (Fig. 3). Various case series describing both plastic and metal stent placement via transmural EGBD quote technical success rates of 100%.8-11 A recent systematic review reported pooled success and significant adverse event rates of 96.7% and 5.5%, respectively, for transmural EGBD in 90 cases.12 Although both routes of EGBD have been shown to be highly successful with minimal adverse events, the role of EGBD in the management algorithm of cholecystitis has not been confirmed because of a paucity of comparative data with percutaneous drainage. The only comparative study in the literature is a randomized controlled trial evaluating 30 and 29 patients having undergone endoscopic naso-gallbladder drainage or PGBD, respectively.13 Both groups had similar technical success, clinical success, and adverse event rates, but the endoscopic groups had lower postprocedure pain scores. Thus, EGBD may offer poor surgical candidates a less-invasive, equally successful, and less-morbid option for gallbladder drainage than 2 GASTROINTESTINAL ENDOSCOPY Volume
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Figure 1. Deployment of a 7F 15-cm double-pigtail plastic stent into the gallbladder from the transpapillary position.
PGBD. This study retrospectively compares outcomes in a series of 73 patients having undergone EGBD or PGBD at a single academic tertiary care center.
METHODS The study was approved by the institutional review board of Weill Cornell Medical College. The charts of inpatients from July 2011 through November 2013 with an inpatient ICD-9 code for a diagnosis of cholecystitis at a single academic tertiary care center were reviewed retrospectively. Any patient deemed not to be a surgical candidate and thus requiring minimally invasive drainage (PGBD or EGBD) was included in the analysis. Patient demographics along with procedural and clinical outcomes were recorded for each group.
Outcome variables Patient demographic variables, including age and sex, were recorded. All patients underwent a radiographic study (abdominal US or CT ) to distinguish the type of cholecystitis (calculous vs acalculous). Details regarding each patient’s hospitalization, including length of stay, date of procedure, and length of stay after the procedure, were recorded. All patients underwent either EGBD or PGBD, and their data were analyzed in the group of their initial intervention for cholecystitis. Details of the intervention, including type (PGBD vs EGBD), number of sessions, and technical success, were detailed. Endoscopic drainage was performed by 1 of 2 routes of drainage (transpapillary vs transmural). The clinical outcomes and hospital course variables were included, such as clinical resolution of cholecystitis, time to clinical resolution, postprocedure pain, and adverse events. The long-term clinical outcomes www.giejournal.org
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Endoscopic vs percutaneous gallbladder drainage
Figure 2. Endosonographic-guided puncture of the gallbladder with a 19-gauge EUS-FNA needle.
regarding adverse events, need for repeat intervention, and length of follow-up were recorded.
Definitions Although all patients included in the analysis had an ICD-9 code for cholecystitis, their charts were reviewed to ensure they met the Tokyo guidelines for cholecystitis, which included a constellation of classic symptoms (right upper quadrant pain, fever, leukocytosis) along with correlating radiographic findings (abdominal US or CT scan).14 Patients were stratified into calculous versus acalculous cholecystitis by the findings on their radiographic study. Technical success was defined as the ability to place a drainage catheter or stent into the gallbladder whether it was by the percutaneous or endoscopic route. Clinical success was defined by improvement in the patient’s overall clinical picture in terms of fevers, leukocytosis, pain, and ability to tolerate oral intake. Immediate and 7-day postprocedure adverse events were recorded. Ward nurses recorded patients’ pain levels on every shift change using a visual analog scale. The highest pain score within 1 day after the procedure was designated as the postprocedure pain score. Any procedure required to place, maintain, or remove a drainage device (stent, catheter) was considered a procedural session. Any patient who underwent further gallbladder intervention (surgical, PGBD, or EGBD) because of persistent symptoms of cholecystitis from inadequate drainage from the initial procedure or recurrence of symptoms because of loss of efficacy from the initial procedure was included in the reintervention group.
Procedure technique PGBD was performed by expert interventional radiologists at our tertiary care center using intravenous conscious www.giejournal.org
Figure 3. Deployment of a transmural fully covered metal stent into the gallbladder with expression of pus.
sedation. The procedures were performed in the interventional radiology suite using sterile technique, and either 8F or 10F catheters (All Purpose Drainage Catheter; Boston Scientific, Natick, Mass) were placed. Patients were routinely brought back after 6 to 8 weeks for catheter check under fluoroscopy and removal. All EGBDs were performed by 2 expert biliary endoscopists (M.K., R.Z.S.), either in the endoscopy suite or the operating room depending on the stability of the patient. Endoscopic drainage was performed in either a transpapillary or transmural approach. Transpapillary drainage was always the first choice for gallbladder drainage before converting to transmural drainage. To perform transpapillary drainage, biliary cannulation was performed with a standard duodenoscope (TGF-Q180V; Olympus, Center Valley, Pa). Using various catheters (Autotome Rx; Boston Scientific, and Swing Tip; Olympus) and wires (Hydra Jagwire; Boston Scientific, and Glidewire; Terumo, Somerset, NJ), they obtained access to the gallbladder through the cystic duct. The wire was coiled deep into the gallbladder fossa. The cystic duct was subsequently dilated with 6F to 8F dilators (Soehendra; Cook Medical, Winston-Salem, NC) over the wire. Then either a 5F or 7F tapered plastic double-pigtail stent (Zimmon; Cook Medical) was inserted over the wire and deployed with 1 pigtail in the gallbladder fossa and the other across the ampulla into the duodenal lumen. Endoscopic sphincterotomy was performed in all transpapillary stent placements. If transpapillary drainage was not possible because of cystic duct obstruction or tortuosity, then transmural drainage was performed. To do this, a linear echoendoscope Volume
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(GF-UCT180; Olympus) was used to identify the gallbladder from the gastric antrum or duodenal bulb by endosonography. Every attempt was made to access the gallbladder from the transduodenal position if possible. After checking local vasculature with color-flow Doppler, the gallbladder was punctured with a 19-gauge needle (ECHO-19; Cook Medical). Bile aspiration of the needle confirmed position within the gallbladder and was sent for culture. Subsequently a .035-inch wire (Hydra Jagwire; Boston Scientific) was advanced through the needle and coiled in the gallbladder. Then, the tract was dilated over the wire with a 4-mm 4-cm dilating balloon (Hurricane; Boston Scientific). Subsequently, either a 10-mm 6-cm or 10-mm 8-cm fully covered metal biliary stent (VIABIL; W.L. Gore Associates, Utica, NY) was deployed into the gallbladder fossa to create either a cholecystoduodenostomy or cholecystogastrostomy. To prevent migration, a 10F double-pigtail plastic stent (Boston Scientific) was deployed through the metal transmural gallbladder stent.
Statistical analysis The c2 test or Fisher exact test was used for categorical variables and t test for continuous variables. P % .05 was considered significant. All statistical analysis was performed by using STATA 13.0 (StataCorp, College Station, Tex). All authors had access to the study data and reviewed and approved the final manuscript.
RESULTS Between 2011 and 2013, 1355 inpatients had a diagnosis code of cholecystitis at our institution. Seventy-three patients (5.4%) were deemed unfit surgical candidates and underwent gallbladder drainage. The mean ages for PGBD and EGBD patients were 66.9 18.0 and 62.5 18.3, respectively. Among patients who underwent drainage of symptomatic cholecystitis, 30 (41.1%) were treated with endoscopic drainage (24 transpapillary, 6 transmural) and 43 (58.9%) with percutaneous drainage. The mean duration of follow-up for the cohort of patients in this study was 9.4 months (percutaneous drainage) and 8.8 months (endoscopic drainage), P Z .38. There were no significant differences between the groups with regard to demographics, concomitant choledocholithiasis, and baseline severity index (Table 1). All patients with choledocholithiasis underwent biliary decompression via ERCP. There was no significant difference in the etiology of cholecystitis between the 2 groups. There was a significant difference in the use of general anesthesia between the 2 groups because it was used in all endoscopic procedures and only 16.7% of the percutaneous procedures. There was no difference in technical success between EGBD (100%) and PGBD (97.6%), P Z .58. There was no difference between clinical resolution between the 4 GASTROINTESTINAL ENDOSCOPY Volume
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TABLE 1. Demographic and baseline clinical variables P value
Endoscopy
PGBD
Age, y
62.5 18.3
66.9 18.0
.15
Sex (M)
14
23
.23
Underlying pathology Calculous
16
29
Acalculous
14
14
Total follow-up time
8.9 7.3
9.4 8.4
.39
Concomitant choledocholithiasis
13 (43.3%)
9 (20.1%)
.068
Mean Charlson Comorbidity Index
6.1
5.6
.47
100%
16.3%
.0001
General anesthesia
PGBD, Percutaneous gallbladder drainage.
PGBD and EGBD groups: 97.6% versus 87%; P Z .08. The mean time to clinical resolution was significantly higher in the percutaneous group, at 4.6 days, versus the endoscopic group, at 2.95 days, P Z .05. The mean number of sessions for the PGBD and EGBD was 2.0 versus 1.06, P ! .0001. The mean postprocedure pain score was 2.1 for the endoscopic group and 3.8 for the percutaneous group, P Z .028. The reintervention rate was significantly higher in the percutaneous drainage group compared with the endoscopic drainage group (53% vs 13%; P Z .004) (Table 2). The median number of adverse events was significantly higher for the PGBD group than for the EGBD group (17 vs 4, P Z .013). There were no differences in the rates of early adverse events (5 vs 4) between PGBD and EGBD, P Z .55. Adverse events in the EGBD group included sphincterotomy bleeding (2), worsening cholecystitis (1), and stent migration (1). Adverse events in the PGBD included catheter dislodgment (6), catheter migration (2), catheterrelated pain (1), catheter occlusion (1), cellulitis (1), perihepatic abscess (1), intraperitoneal bleeding (1), cholecystitis (1), cholangitis (1), myocardial infarction (1), and mechanical fail during procedure (1). Significantly more late adverse events (12 vs 0) occurred in the PGBD group, P ! .0001. Patients undergoing PGBD had a significantly longer length of hospital stay (16.3 vs 7.6 days, P Z .04). Subgroup analysis comparing outcomes between the patients who underwent transpapillary endoscopic drainage (n Z 24) versus PGBD was similar to the overall comparison. There was no difference in clinical success between the 2 groups (P Z .127), whereas transpapillary endoscopic drainage had fewer adverse events (P Z .046) and a shorter time to clinical resolution (P Z .015).
DISCUSSION As the population continues to age, less-invasive means of managing cholecystitis in high-risk patients will be www.giejournal.org
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TABLE 2. Procedural and clinical outcomes P value
EGBD
PGBD
Technical success
100%
97.6%
.58
Clinical success
26/30
42/43
.08
Number of sessions
1.0
2 (1-5)
.000
Time to clinical success, days
2.95
4.6
.05
4
17
.013
Adverse events Early
4
5
.55
Late
0
12
!.0001
2.1
3.8
.028
4
23
.001
7.6
16.3
.046
Postprocedural pain No. of subjects with repeat interventions Length of stay postprocedure, days
EGBD, Endoscopic gallbladder drainage; PGBD, percutaneous gallbladder drainage.
needed given the mortality risk of 30% with surgery in this population.15 With the increasing intraductal precision of ERCP and the advent of interventional EUS, endoscopic drainage of the gallbladder is not only feasible but also safe. However, because of the longstanding convention of using PGBD, the general medical community has not yet recognized or clarified the role of EGBD in the management algorithm of high-risk cholecystitis. Although PGBD is effective, generally safe, and relatively convenient in morbid patients, it is significantly limited by its nonphysiologic drainage of the biliary system and long-term catheter-related adverse events. EGBD offers a less-invasive solution to both of these issues. Limited studies have compared these 2 modalities. Our study is the largest comparison of these 2 techniques in a nonsurgical population with cholecystitis. Although this was a retrospective analysis, both populations in this study were of similar age, gender, and baseline clinical severity and had a similar length of follow-up. In addition, all patients were poor surgical candidates because of comorbidities. Of all variables analyzed, PGBD and EGBD were similar only in their technical and clinical success rates. Although the rate was not statistically significant, we attribute the slightly lower clinical success rate of EGBD as compared with PGBD to the small sample size of the study. We performed a subgroup analysis comparing the transpapillary endoscopic drainage versus PGBD because most endoscopic patients were drained via this method. There were not enough patients to perform subgroup analysis for the transmural endoscopic drainage group. The transpapillary subgroup analysis yielded similar comparative results with the overall analysis. This implies that the small number of transmural patients was not the underlying reason for more favorable outcomes in the overall EGBD group compared with PGBD. In all other categories, EGBD was superior to PGBD in terms of efficiency, safety, tolerability, and long-term efficacy. From a fiscal and logistical standpoint, EGBD requires www.giejournal.org
fewer sessions than PGBD for completion of therapy and also is associated with a significantly shorter postprocedure length of hospitalization. Because EGBD via transpapillary or transmural stent placement can be a definitive treatment, not requiring removal or revision, it is expected to have fewer sessions than PGBD. Percutaneous drains are generally removed after 6 to 8 weeks of placement for patient comfort and to reduce the risk of infection and fistula formation. Thus, PGBD requires at least 2 sessions for completion of therapy. However, frequently more than 2 sessions are required because of catheter clogging or migration. In our study, 32.5% of PGBD procedures required more than 2 sessions before completion of therapy. In addition, the postprocedure length of stay was significantly shorter for EGBD than PGBD. This may be because of a significantly shorter time to clinical resolution of disease in EGBD patients compared with PGBD. The reason for this is not clear because the baseline clinical severity of both groups was similar. However, it may be related to the caliber of the stent used for drainage. Another reason is that patients may need a longer period to adjust to their percutaneous catheters and to the higher pain associated with them before feeling comfortable leaving the hospital. A previous randomized controlled trial has shown that endoscopic therapy results in lower pain scores for patients compared with percutaneous modalities. Our study confirmed this notion, with the pain score for EGBD being almost 50% lower than PGBD 1 day after the procedure. EGBD may avoid the psychosomatic issues that result from external catheter drainage. Minimizing the number of sessions required for therapeutic completion along with the postprocedure pain and days of hospitalization may result in significant cost savings and improved quality of life for the patient. Because the mean follow-up period for both groups was on the order of about 9 months, the long-term adverse events of both techniques could be assessed. PGBD had significantly more long-term adverse events, most of which were catheter-related, compared with EGBD. The most common of these was catheter dislodgement, resulting in either dysfunction or complete removal of the device, thus requiring repeat intervention in many cases. In only 1 EGBD case was there concern for stent migration, which was recognized acutely and revised soon after the procedure. Most EGBD-related adverse events were related to the risk of ERCP itself, which included sphincterotomyrelated bleeding and postprocedure pancreatitis. In our series, 2 patients required repeat intervention for sphincterotomy bleeding, and none endured post-ERCP pancreatitis. Although these are some of the adverse events specific to EGBD and not PGBD, we expect them to mitigate with the increased performance of EUS-guided transmural EGBD. Some adverse events specific to PGBD include pneumothorax and hemobilia. Adverse events common to both Volume
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techniques include pneumoperitoneum and bile leak. Although pneumoperitoneum is expected in both procedures, it is rarely a clinically significant adverse event. Bile leak and subsequent peritonitis, on the other hand, are significant and must be avoided. Only 1 case of bile peritonitis has been reported in the transmural EGBD literature.9 With the approval and availability of new fully covered lumen-apposing metal stents, this risk may also be abated.10,16,17 Although the technical and clinical success rates of the 2 techniques were similar in the short term, the long-term efficacy is an issue of great clinical and economic importance. There are limited data on the long-term viability of EGBD because of its recent inception; however, early data are encouraging. One study reported an absence of recurrence of cholecystitis in 93.5% after EGBD in up to 5 years of follow-up.18 Another prospective multicenter study of 29 patients having undergone transpapillary EGBD reported a 2-year patency rate of 80%.19 This is compared with the reported cumulative recurrent cholecystitis rate of 33% 2 years after percutaneous drain removal. Another study reported a 22% recurrence of cholecystitis at a median of 151 days after catheter removal.4 In our study, both groups had a similar follow-up range. The PGBD arm had almost 6 times as many reinterventions for gallbladder drainage than the EGBD group either because of inadequate drainage from the existing catheter, catheter migration, or ongoing symptoms of cholecystitis. A comparison of the long-term efficacy of these 2 techniques has never been reported. We believe that because of the instability of the percutaneous catheter position over time related to regular “wear and tear” along with an increased likelihood for physical tampering, its longterm efficacy compared with EGBD is significantly inferior. This concept needs further study to confirm these findings but could have significant implications on the superiority of 1 technique over the other in terms of being a definitive therapy. We recognize that the retrospective nature and relatively small sample size are limitations of this study. However, this is the largest comparison of EGBD and PGBD published to date, reporting not only short-term but also long-term clinical variables related to treatment of cholecystitis. Although EGBD has similar rates of immediate clinical and technical success as PGBD, it is associated with utilization of fewer inpatient resources, fewer adverse events, lower pain scores, quicker clinical response, and a decreased need for repeat gallbladder intervention. EGBD may provide a less-invasive, less-painful, safer, and more cost-effective option for gallbladder drainage than PGBD in the short- and long-term outlook in cholecystitis management. Further prospective comparative studies are needed to decide its role in the management algorithm of high-risk patients with this disease.
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REFERENCES 1. Chopra S, Dodd GD 3rd, Mumbower AL, et al. Treatment of acute cholecystitis in non-critically ill patients at high surgical risk: comparison of clinical outcomes after gallbladder aspiration and after percutaneous cholecystostomy. AJR Am J Roentgenol 2001;176:1025-31. 2. Itoi T, Coelho-Prabhu N, Baron TH. Endoscopic gallbladder drainage for management of acute cholecystitis. Gastrointest Endosc 2010;71: 1038-45. 3. Winbladh A, Gullstrand P, Svanvik J, et al. Systematic review of cholecystostomy as a treatment option in acute cholecystitis. HPB (Oxford) 2009;11:183-93. 4. Sanjay P, Mittapalli D, Marioud A, et al. Clinical outcomes of a percutaneous cholecystostomy for acute cholecystitis: a multicentre analysis. HPB (Oxford) 2013;15:511-6. 5. Dawson PA. Bile secretion and the enterohepatic circulation of bile acids. In: Feldman M, Friedman LS, Sleisenger MH, eds. Sleisenger and Fordtran’s gastrointestinal and liver disease, 7th ed, Vol 1. Philadelphia, PA: Saunders; 2002. p. 1055. 6. Itoi T, Sofuni A, Itokawa F, et al. Endoscopic transpapillary gallbladder drainage in patients with acute cholecystitis in whom percutaneous transhepatic approach is contraindicated or anatomically impossible (with video). Gastrointest Endosc 2008;68:455-60. 7. Kozarek. Selective cannulation of the cystic duct at time of ERCP. J Clin Gastroenterol 1984;6:37-40. 8. Hasan MK, Itoi T, Varadarajulu S. Endoscopic management of acute cholecystitis. Gastrointest Endosc Clin North Am 2013;23:453-9. 9. Song TJ, Park DH, Eum JB, et al. EUS-guided cholecystoenterostomy with single-step placement of a 7F double-pigtail plastic stent in patients who are unsuitable for cholecystectomy: a pilot study (with video). Gastrointest Endosc 2010;71:634-40. 10. Itoi T, Binmoeller KF, Shah J, et al. Clinical evaluation of a novel lumenapposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos). Gastrointest Endosc 2012;75:870-6. 11. Jang JW, Lee SS, Park DH, et al. Feasibility and safety of EUS-guided transgastric/transduodenal gallbladder drainage with single-step placement of a modified covered self-expandable metal stent in patients unsuitable for cholecystectomy. Gastrointest Endosc 2011;74: 176-81. 12. Widmer J, Singhal S, Gaidhane M, et al. Endoscopic ultrasound-guided endoluminal drainage of the gallbladder. Dig Endosc 2014;26:525-31. 13. Jang JW, Lee SS, Song TJ, et al. Endoscopic ultrasound-guided transmural and percutaneous transhepatic gallbladder drainage are comparable for acute cholecystitis. Gastroenterology 2012;142: 805-11. 14. Hirota M, Takada T, Kawarada Y, et al. Diagnostic criteria and severity assessment of acute cholecystitis: Tokyo guidelines. J Hepatobil Pancreat Surg 2007;14:78-82. 15. Frazee R, Nagorney D, Mucha PJ. Acute acalculous cholecystitis. Mayo Clin Proc 1986;64:163-7. 16. Mönkemüller K, Zabielski M, Didowacz-Grollmann A, et al. Endoluminal transgastric endoscopic anastomosis of the gallbladder using an anchoring self-expanding metal stent. Endoscopy 2013;45(Suppl 2): E164-6. 17. Kedia P, Boumitri C, Sharaiha RZ, et al. Conversion of a percutaneous cholecystotomy tube into an internal cholecystogastrostomy using a novel anastomotic stent. Gastrointest Endosc 2014;81:228-9. 18. Maekawa S, Nomura R, Murase T, et al. Endoscopic gallbladder stenting for acute cholecystitis: a retrospective study of 46 elderly patients aged 65 years or older. BMC Gastroenterol 2013;13:65. 19. Lee TH, Park DH, Lee SS, et al. Outcomes of endoscopic transpapillary gallbladder stenting for symptomatic gallbladder diseases: a multicenter prospective follow-up study. Endoscopy 2011;43:702-8.
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