Original article
315
Endoscopic treatment of nonstricture-related benign biliary diseases using covered self-expandable metal stents
Authors
Shayan Irani1, Todd H. Baron2, Ryan Law2, Ali Akbar2, Andrew S. Ross1, Michael Gluck1, Ian Gan1, Richard A. Kozarek1
Institutions
1
submitted 17. June 2014 accepted after revision 14. October 2014
Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1391093 Published online: 18.12.2014 Endoscopy 2015; 47: 315–321 © Georg Thieme Verlag KG Stuttgart · New York ISSN 0013-726X Corresponding author Shayan Irani, MD Digestive Disease Institute Virginia Mason Medical Center 1100 9th Ave., MS: C3-GAS Seattle, WA 98111 United States Fax: +1-206-223-6379 [email protected]
Department of Gastroenterology, Virginia Mason Medical Center, Seattle, Washington, United States Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, United States
Background and study aims: Nonstricture benign biliary diseases (BBDs) such as leaks, perforations, and bleeding, have been traditionally managed by placement of one or more plastic stents. Emerging data support the use of covered, self-expandable, metal stents (CSEMSs). The aim of this study was to assess the outcomes of endoscopic temporary placement of CSEMS in patients with nonstricture BBD. Patients and methods: This was a retrospective study of CSEMS placement for BBD between May 2005 and August 2013 at two tertiary care centers. The main outcome measures were resolution of perforation, bleeding, leak, and adverse events related to CSEMS treatment. Results: A total of 87 patients were included (median age 62 years [range 18 – 86]). Indications for stent placement were bile leaks (n = 35, 40 %),
bleeding (n = 27, 31 %), perforation (n = 18, 21 %), and other conditions (n = 7, 8 %). Fully and partially covered 8 – 10-mm diameter CSEMS were placed and subsequently removed in all 87 patients (100 %). Resolution of the underlying problem was achieved for 33 bile leaks (94 %), 25 bleedings (93 %), 18 perforations (100 %), and for 3 cases with other indications (43 %). The median duration of stenting was 9 weeks in patients with biliary leaks, 3 weeks for bleeding, and 9.5 weeks for perforations. Median follow-up was 82 weeks after stent removal. Seven adverse events occurred, including cholangitis in six patients (7 %), and tissue hyperplasia leading to difficulty in the removal of a partially covered SEMS in one patient. Conclusions: Nonstricture BBD can be effectively and safely treated with the short term placement of CSEMS.
Introduction
transpapillary plastic stents [4], biliary sphincterotomy alone [4], or a combination of the two, is the first-line treatment for biliary leaks [2, 4]. Recent data suggest a combination of biliary sphincterotomy and placement of a transpapillary biliary stent results in better outcomes for high grade bile leaks [2, 15]. Endoscopic management of bile leaks with plastic stents is safe and efficacious [2, 4, 16, 17]. However, difficult-to-treat, refractory bile leaks may require multiple endoscopic interventions or surgery [2, 4]. Complications of endoscopic sphincterotomy include bleeding [5, 18, 19] and perforation [18, 20]. Post-sphincterotomy bleeding rates vary from 0.76 % – 2 % to 10 % – 48 % [5, 19, 21], and can be immediate or delayed [5, 22, 23]. Endoscopic therapies include epinephrine injection, thermal therapy, balloon tamponade, clips, and placement of large-bore plastic stents (10 Fr or larger) to tamponade the bleeding site and to maintain biliary drainage [1, 15, 19]. Refractory bleeding may require angiographic embolization or surgery [5, 19]. There have been several reports of bleeding
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Plastic stents are used to treat benign biliary disease (BBD) [1], such as biliary leaks [2 – 4], postsphincterotomy bleeding [5], and iatrogenic perforations [6]. Self-expandable metal stents (SEMSs) were introduced to prolong stent patency by increasing the luminal diameter. Uncovered SEMSs embed into the bile duct making removal virtually impossible [1, 7, 8]. Covered SEMSs (CSEMSs) were introduced to prolong stent patency by reducing tissue ingrowth. Plastic stents are effective for most biliary leaks, bleeding, and perforations, but their limited diameters may fail to resolve the underlying disorder [9]. Advantages of CSEMSs over plastic stents include small pre-deployment and large post-expansion diameters, with the ability to close perforations and tamponade bleeding. In addition, CSEMSs do not embed and are removable [10 – 14]. Biliary leaks most commonly occur following laparoscopic cholecystectomy [2, 15]. Placement of
Irani Shayan et al. Covered, self-expandable, metal stents for biliary diseases … Endoscopy 2015; 47: 315–321
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Original article
encountered from varices and tumors invading the bile duct [9]. Post-sphincterotomy perforations occur in 0.35 % – 0.72 % of cases [6, 20]. Endoscopic placement of transpapillary plastic stents is efficacious in most cases and surgery is occasionally required [6, 20, 21]. CSEMSs have been used to effectively treat biliary leaks, perforations, and other biliary disorders, but data are limited [1, 9, 11, 24]. The aim of the current study was to report the outcome following placement of CSEMSs for the treatment of various nonstricture BBD.
Table 1 Patient characteristics and indications for placement of covered, self-expandable, metal stents in patients with nonstricture-related benign biliary disease (n = 87). Age, median (range), years
62 (18 – 86)
Sex, male/female, n
47/40
Weight, median (range), kg
71 (39 – 128)
Indication, n Biliary leak
35
Post-cholecystectomy
24
Abscess/pancreatic necrosis
10
Post EUS-biliary rendezvous Bleeding, n
Patients and methods
Post-sphincterotomy
!
Bile duct varices
Patients
Bleeding neuroendocrine tumor
The endoscopy and billing databases of two tertiary care medical centers (Virginia Mason Medical Center, Seattle and Mayo Clinic, Rochester) were reviewed from May 2005 to August 2013 to identify patients with nonstricture BBD who had undergone temporary placement of a CSEMS. Pre-procedural, procedural, and post-procedural details were recorded. Information was obtained via telephone contact with referring providers and review of outside records for patients who received follow-up at other institutions. The study was approved by the Institutional Review Boards of both institutions.
Stent placement procedure Written informed consent was obtained from all patients. Most procedures (60 %) were performed with the patient under moderate sedation. Endoscopists were experienced in biliary therapy (≥ 300 endoscopic retrograde cholangiopancreatographies [ERCPs] per year) and used standard video duodenoscopes (TJF140, 160, 180 series; Olympus America Inc., Center Valley, Pennsylvania, USA) for patients with conventional anatomy, and an adult colonoscope (CF-160, CF-180, Olympus America Inc.) for patients with biliary-enteric anastomoses. The previous use of plastic stents, including number and diameter, was recorded. Presence or absence of a gallbladder and relationship of the CSEMS to the cystic duct takeoff was noted. Duration of CSEMS placement was based on endoscopist recommendations and the patient’s ability to return. Planned CSEMS removal was 2 weeks after percutaneous drain removal for biliary leaks, 4 – 6 weeks for iatrogenic perforations, and 2 weeks for post-sphincterotomy bleeding. CSEMS removal was performed by grasping the stent with a standard polypectomy snare and either withdrawing the endoscope with the stent or withdrawing the stent through the instrument channel. Adverse events were recorded as those occurring during the CSEMS dwell period and those occurring at or within 30 days after CSEMS removal. Adverse events were defined and graded in severity according to accepted criteria [25]. Success was defined clinically and radiologically (at follow-up ERCP) and after removal of percutaneous drains, if present.
Results !
Indications for stent placement A total of 87 patients were identified (47 males, median age 62 years) who underwent CSEMS placement and removal for nonstricture BBD. Of these patients, 35 (40 %) had biliary leaks, 27
Perforation, n Post-sphincterotomy
1 27 23 3 1 18 12
Biliary-enteric anastomosis Other, n
6 7
Removal of partially covered SEMS
3
Facilitate biliary stone removal
2
Sump syndrome
1
Choledochogastric fistula
1
EUS, endoscopic ultrasound; SEMS, self-expandable metal stent.
(31 %) had bleeding, 18 (21 %) had perforations (12 post-sphincterotomy and 6 perforations associated with balloon dilation of biliary enteric anastomoses), and 7 patients (8 %) had other conditions. The latter included attempted removal of previously placed partially covered SEMSs at other institutions (n = 3), biliary stone removal (n = 2), sump syndrome (n = 1), and choledocho" Table 1). The outcome of the 35 patients gastric fistula (n = 1) (● with biliary leak has been reported previously [9]. Bile leaks (n = 35) occurred after cholecystectomy (n = 24), severe acute pancreatitis (n = 10), or after endoscopic ultrasound (EUS)biliary rendezvous (n = 1). Refractory bile leaks were defined by failure to respond (persistent high output from percutaneous drain or persistent leak at cholangiography) to a 10-Fr plastic stent and biliary sphincterotomy for more than 2 weeks (n = 25) " Fig. 1). Large bile leaks were defined by contrast extrava[2, 4] (● sation without filling the intrahepatic ducts (n = 9). In these nine cases, CSEMSs were placed as the initial endoscopic therapy as per the preference of the endoscopist because it was believed that plastic stent therapy was likely to fail. Successful resolution of the biliary leak was defined by removal of the percutaneous drain (after output from the drain dropped below 5 mL/day) with no recurrence for at least 4 weeks after CSEMS removal " Table 2). (● Refractory post-sphincterotomy bleeding (n = 23), defined as failure to respond to epinephrine injection and thermal therapy with or without hemostatic clips, was the most common cause " Fig. 2). Three patients had bile of bleeding from the bile duct (● duct variceal bleeding, and one patient had a bleeding pancreatic neuroendocrine tumor with recurrent hemobilia and cholangitis. Perforation (n = 18) was defined as presence of free or retroperitoneal air visualized fluoroscopically in addition to an obvious full-thickness defect and contrast extravasation at the sphincter" Fig. 3, otomy site (n = 12), or biliary-enteric anastomosis (n = 6) (● ●" Video 1). Miscellaneous disorders included: three cases of previously placed partially covered SEMSs (failure to remove at previous endoscopy); two cases in which CSEMS was used to facilitate
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large bile duct stone removal; one case of choledochogastric fistula, which resulted in recurrent cholangitis occurring after partial hepatectomy and chemoembolization for liver metastases; and one case of sump syndrome, defined as recurrent biliary obstruction caused by food, stones, or debris after choledochoenterostomy.
Outcomes of stent treatment Removability All CSEMSs were successfully removed. Removal was difficult in only one patient, who had received a partially covered SEMS (12/87 patients), through which tissue ingrowth had occurred; a second endoscopic procedure was required for removal of this stent.
Stent duration The median duration of stent placement was 9 weeks (range 2 – 115 weeks) for patients with bile leaks, 3 weeks (range 1 – 11 weeks) for patients with post-sphincterotomy bleeding, 9.5 weeks (range 4 – 14 weeks) for patients with perforations, and
Table 2
12 days for stent-in-stent removal of previously placed partially covered SEMSs. For patients with bleeding bile duct varices, a CSEMS was left in place for 18 and 12 months respectively in two patients, who later died from complications of metastatic pancreatic cancer. No recurrent bleeding occurred during the period of stent dwell. A third patient with inoperable serous cystadenoma of the pancreas required placement of two partially covered SEMSs during a total stent dwell time of 22 months. The fourth patient with recurrent cholangitis and hemobilia caused by a neuroendocrine tumor of the pancreatic head had no recurrence of bleeding following the stent placement 6 months pre" Table 3). viously (●
Resolution of underlying problem Bile leaks resolved in all but two of the 35 patients (6 %), with one patient dying from an infected biloma and the second patient requiring placement of an additional plastic stent into the cystic duct stump to facilitate leak resolution. Notably, in patients with post-cholecystectomy bile leaks, some CSEMSs were placed above the leak site and some below; only one patient, who had a
Site of bile leak (n = 35).
Site of bile leak
CSEMS above cystic duct
Cystic duct stump
CSEMS below cystic duct
Gallbladder
15
4
Absent
Gallbladder remnant
1
1
Remnant only
Duct of Luschka
3
0
Absent
Common bile duct
4
1
Absent
Common bile duct
0
6
Present
CSEMS, covered self-expandable metal stent.
Irani Shayan et al. Covered, self-expandable, metal stents for biliary diseases … Endoscopy 2015; 47: 315–321
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Fig. 1 Biliary leak. a Sphincterotomy and placement of a plastic stent was performed to treat the leak. b After 2 weeks of plastic stent therapy the leak has not resolved. c The site was treated successfully with a fully covered, self-expandable, metal stent placed above the level of the leak. d Complete resolution of the leak at endoscopic retrograde cholangiopancreatography 6 weeks later.
Original article
Fig. 2 Post-sphincterotomy bleeding. a Sphincterotomy performed for stone extraction. b Bleeding occurred 2 days later and failed to respond to epinephrine and thermal therapy. c, d A fully covered, self-expandable, metal stent was placed with successful resolution of bleeding. The stent remained in place for 10 days.
Fig. 3 Perforation. a Post-sphincterotomy perforation with retroperitoneal leakage of contrast (arrow) after balloon dilation and stone extraction. b Endoscopic view. c The perforation was successfully treated by placement of a fully covered, selfexpandable, metal stent for 5 weeks. d Endoscopic view.
bile leak and an intact gallbladder, had a CSEMS placed across the cystic duct, with no adverse events. In patients with bile leaks from the cystic duct or gallbladder, there was no difference in
stent dwell time when CSEMS were placed above the cystic duct (n = 16; median 6.5 weeks) or below the cystic duct (n = 5; median 8 weeks; P = 0.33).
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Original article
Table 3 Post-procedural details of patients undergoing covered self-expandable, metal stent placement in nonstricture-related benign biliary disease (n = 87). Prior plastic stent use, n (%)
32 (37)
Type of stent, n (%)
87
Wallstent (partially covered)
12 (14)
Table 4 Adverse events in patients undergoing covered self-expandable metal stent placement for nonstricture-related benign biliary disease (n = 87). During and after placement, n (%) Cholangitis At and after removal, n (%)
87 4 87
Wallflex (10 mm)
29 (33)
Cholangitis
2
Viabil
46 (53)
Tissue hyperplasia with difficulty removing SEMS
1
8 mm
11
10 mm
35
319
Unrelated deaths, n (%)
3
SEMS, self-expandable metal stent.
Biliary leak
9 (2 – 115)
Bleeding
3 (1 – 11)
Perforation
9.5 (4 – 14)
Resolution of underlying problem, n (%) Biliary leak
33/35 (94) 1
Bleeding
25/27 (93) 2
Perforation
18/18 (100)
Other indications
3/7 (43)
Removal of partially covered SEMS
2/3
Facilitate biliary stone removal
1/2
Sump syndrome
0/1
Choledochogastric fistula Follow-up after stent removal, median, weeks
0/1 82
SEMS, self-expandable metal stent. 1 One patient died from sepsis from infected biloma and another patient failed. 2 One patient re-bled after being restarted on Coumadin, and another while on clopidogrel.
Perforations successfully closed in all 18 patients (biliary-enteric anastomosis n = 6, post-sphincterotomy n = 12). Patients were hospitalized for a median of 2.5 days (range 1 – 12 days) after CSEMS placement and were treated with antibiotics for a median of 4 days (range 3 – 14 days). Four patients (post-sphincterotomy n = 3, biliary-enteric anastomosis n = 1) required temporary percutaneous drain placement for an infected fluid collection. The remaining patients (n = 14) did not require percutaneous or surgical intervention. In patients with post-sphincterotomy bleeding in whom endoscopic therapy with epinephrine injection and coaptive coagulation had failed, bleeding resolved immediately after CSEMS placement. Two patients required 2 and 3 units of packed red blood cells, respectively, before endoscopic treatment but none required transfusion after treatment. The two cases of treatment failure (with ongoing warfarin and clopidogrel use, respectively) were treated with repeat epinephrine injection, thermal therapy, and hemostatic clips, in addition to cessation of warfarin and clopidogrel treatment for 7 days.
Video 1
Retroperitoneal perforation and air in Online content including video sequences viewable the portal vein after initial attempt at: www.thieme-connect.de to remove a bile duct stone. The perforation was treated successfully at subsequent endoscopic retrograde cholangiopancreatography, with stone removal and placement of a fully covered, metal stent.
Fully covered SEMS placement to facilitate removal of previously placed partially covered SEMSs by using the stent-in-stent technique was successful in two of three patients. The fully covered SEMSs were removed easily in all three patients at 14 days (successful partially covered SEMS removal n = 2) and 7 days (unsuccessful partially covered SEMS removal), respectively. In the patient with sump syndrome (prior biliary sphincterotomy), recurrent cholangitis continued despite CSEMS placement and it was removed 74 days after insertion. Treatment in one of two patients in whom CSEMSs were placed to facilitate biliary stone clearance failed because severe cholangitis developed post-procedurally. Intensive care unit management and vasopressor support was administered and the stent was removed 4 days later. The other patient had choledocholithiasis in the setting of a benign distal bile duct stricture, which prevented stone extraction during previous ERCP. A fully covered SEMS was placed to facilitate stricture dilation with placement of two double-pigtail plastic stents through the CSEMS. Complete ductal clearance was achieved at the time of removal 43 days later.
Adverse events The median follow-up after stent removal was 82 weeks. Adverse " Table 4). Four patients events occurred in 7/87 patients (8 %) (● developed cholangitis during the period of stent placement. One case was mild and responded to outpatient oral antibiotics, two were moderate and required antibiotics and stent removal, and one was severe (mentioned above). Two additional patients developed cholangitis 24 hours after CSEMS removal; cholangitis was mild and was treated with antibiotics and 1 day in hospital in both cases. Asymptomatic tissue hyperplasia was noted at stent removal in three patients with partially covered SEMSs. In two, the CSEMSs were removed without sequelae. However, one patient required side-by-side, 10-Fr plastic stent placement and repeat endoscopy (moderate adverse event) for subsequent endoscopic removal. There were three patient deaths from unrelated causes (one while the CSEMS was in place) at a mean of 226 days after CSEMS placement. Causes of death included prostate cancer (n = 1) and pulmonary embolism (n = 1). The cause of death was unknown in one patient (death occurred 7 weeks after stent removal; care received at an outside facility).
Discussion !
CSEMSs were initially developed to prolong stent patency in malignant biliary obstruction [26], but they now play a role in the treatment of BBD [4, 11, 26 – 28]. The use of CSEMSs to treat refractory or large biliary leaks, bleeding, and perforations produced success rates of 93 % – 100 % in the current study, with minimal adverse events.
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Duration of stent placement, median (range), weeks
Original article
In a series of 13 patients with complex biliary leaks [24], all were successfully closed using fully covered SEMSs. Mucosal ulcerations noted on cholangioscopy at the time of stent removal may have been related to anchoring fins. De novo stricture formation was reported in two patients. However, in a more recent series of 25 patients [21] (refractory biliary leaks n = 17, bleeding n = 4, perforation n = 4), all patients responded to short-term placement of a fully covered SEMS (3 – 30 days), without adverse events. Three patients in the current series developed tissue hyperplasia associated with partially covered SEMSs, with one requiring an additional procedure to remove the CSEMS; however, none of these patients developed a de novo stricture after a median follow up of 32 months. Thus, we recommend against routine placement of partially covered SEMSs for benign disease, especially if the expected stent dwell time is longer than 4 weeks. In the same series of 13 patients [24], choledocholithiasis and/or luminal debris was noted in 10 patients at the time of stent removal compared with only 5 patients in the current series, all of whom were asymptomatic. The median duration of stent placement was 64 days in patients developing biliary debris. SEMSs covered with silicone and polyurethane may be less prone to biofilm formation than expanded polytetrafluoroethylene [13], and may be less likely to develop stone and sludge formation. However, reflux of gastroduodenal contents remains an issue [24]. Patients with refractory biliary leaks (despite sphincterotomy and 2 weeks of plastic stenting) and large biliary leaks were treated by CSEMS placement because of the larger diameter and the ability to “close off” the leak when placed proximal to the site of leakage. Alternatively, upsizing or placement of additional plastic stents could have been used. However, comparative data to guide this decision are lacking, and it must be made on an individual basis. In a series of five patients [29] with difficult-to-treat postsphincterotomy bleeding, temporary fully covered SEMSs were successfully placed for tamponade with a median stent dwell time of 4 weeks. More recently, four patients [21] achieved hemostasis with a median stent dwell time of 6 days (3 – 15 days). In the current study, failure occurred in 2/27 patients (7 %) and was believed to be due to ongoing use of antithrombotics. Both patients responded to further endoscopic therapy and the cessation of anticoagulation therapy for 7 days. The median stent dwell time was 21 days. Based on previous case series [21] and our own experience, we estimate 2 weeks of fully covered SEMS placement is adequate in this setting. In two patients, fully covered SEMSs were used to close perforations after endoscopic sphincterotomy [14]. Stents were removed after a mean dwell time of 96 days. Another four perforations [21] were medically managed without the need for surgery, and patients resumed oral feeding and were discharged within 7 days, with all stents removed within 30 days. All of the 18 patients with perforation in the current study were also successfully treated with CSEMSs (median stent dwell time 9.5 weeks) without the need for surgery, although four patients required percutaneous drainage. In this setting, CSEMS removal was performed 2 – 4 weeks after removal of the percutaneous drainage catheter. This stent dwell time is between those of the two previous case series [14, 21], but we believe that 4 – 6 weeks would be adequate in this setting. The stent-in-stent technique of placing a fully covered SEMS inside an embedded partially covered SEMS for 7 – 14 days to induce pressure necrosis of intervening tissue to allow subsequent removal of esophageal stents [30] has been used to remove un-
covered biliary SEMS in two patients [31, 32]. In the current study, this technique failed in one patient; stent removal was attempted only 7 days after placement of the fully covered SEMS, and a longer dwell time may have been more successful. In fact, the partially covered SEMS was finally removed after 3 months of treatment with multiple plastic stents. Partially covered SEMSs were easily removed in the current series, especially when they extended into the duodenum because only the 5-mm proximal uncovered portion becomes embedded [33]. However, grossly evident luminal occlusion and tissue hyperplasia occurred in three patients with partially covered SEMSs. In contrast, all fully covered SEMSs were easily removed, consistent with previous publications [3]. We suggest partially covered SEMSs should not be used routinely for BBD [34]. Limitations of this study include the retrospective design and the lack of a control group. Consequently the routine use of CSEMSs for treatment of all BBDs cannot be recommended based on the current results. The length of follow-up after stent removal was also relatively short (82 weeks). However, this is the largest series to investigate the management of such patients with CSEMS. In conclusion, CSEMSs are safe and effective for treating nonstricture-related BBDs, especially after failed plastic stent therapy. The cost of CSEMS (range $ 1000 – 1800) is a potential disadvantage compared with plastic stents (range $ 5 – 10). In addition, iatrogenic, proximal strictures may occur after CSEMS placement, especially when there is stent– duct size discordance [35]. This potential complication combined with the risk of sludge and stone formation, and reflux of gastroduodenal contents, should prompt the removal of CSEMS as soon as the underlying problem is resolved. While fully covered SEMSs appear to induce fewer adverse events than partially covered SEMSs, a definite advantage of CSEMSs over plastic stents as primary therapy for benign biliary disorders remains unproven. Competing interests: Virginia Mason Medical Center receives restricted funding for educational purposes from Boston Scientific (BSCI), Cook Medical, and Olympus America Inc. Dr. Baron has received research funding from BSCI.
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23 Masci E, Toti G, Mariani A et al. Complications of diagnostic and therapeutic ERCP: a prospective multicenter study. Am J Gastroenterol 2001; 96: 417 – 423 24 Wang AY, Ellen K, Berg CL et al. Fully covered self-expandable metallic stents in the management of complex biliary leaks: preliminary data – a case series. Endoscopy 2009; 41: 781 – 786 25 Cotton PB, Eisen GM, Aabakken L et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446 – 454 26 Isayama H, Komatsu Y, Tsujino T et al. A prospective randomised study of “covered” versus “uncovered” diamond stents for the management of distal malignant biliary obstruction. Gut 2004; 53: 729 – 734 27 Kahaleh M, Sundaram V, Condron SL et al. Temporary placement of covered self-expandable metallic stents in patients with biliary leak: midterm evaluation of a pilot study. Gastrointest Endosc 2007; 66: 52 – 59 28 Devière J, Nageshwar Reddy D, Püspök A et al. Successful management of benign biliary strictures with fully covered self-expanding metal stents. Benign Biliary Stenoses Working Group. Gastroenterology 2014; 147: 385 – 395 29 Shah J, Marson F, Binmoeller K. Temporary self-expandable metal stent placement for treatment of post-sphincterotomy bleeding. Gastrointest Endosc 2010; 72: 1274 – 1278 30 Hirdes MM, Siersema PD, Houben MH et al. Stent-in-stent technique for removal of embedded esophageal self-expanding metal stents. Am J Gastroenterol 2011; 106: 286 – 293 31 Arias Dachary FJ, Chioccioli C, Deprez PH. Application of the “covered stent-in-uncovered-stent” technique for easy and safe removal of embedded biliary uncovered SEMS with tissue ingrowth. Endoscopy 2010; 42: E304 – 305 32 Tan DM, Lillemoe KD, Fogel EL. A new technique for endoscopic removal of uncovered biliary self-expandable metal stents: stent-in-stent technique with a fully covered biliary stent. Gastrointest Endosc 2011; 75: 923 – 925 33 Kahaleh M, Tokar J, Le T et al. Removal of self-expandable metallic Wallstents. Gastrointest Endosc 2004; 60: 640 – 644 34 Kasher JA, Corasanti JG, Tarnasky PR et al. A multicenter analysis of safety and outcome of removal of a fully covered self-expandable metal stent during ERCP. Gastrointest Endosc 2011; 73: 1292 – 1297 35 Irani S, Baron TH, Akbar A et al. Endoscopic treatment of benign biliary strictures using covered self-expandable metal stents (CSEMS). Dig Dis Sci 2014; 59: 152 – 160
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Endoscopic treatment of nonstricture-related benign biliary diseases using covered self-expandable metal stents
Authors
Shayan Irani1, Todd H. Baron2, Ryan Law2, Ali Akbar2, Andrew S. Ross1, Michael Gluck1, Ian Gan1, Richard A. Kozarek1
Institutions
1
submitted 17. June 2014 accepted after revision 14. October 2014
Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1391093 Published online: 18.12.2014 Endoscopy 2015; 47: 315–321 © Georg Thieme Verlag KG Stuttgart · New York ISSN 0013-726X Corresponding author Shayan Irani, MD Digestive Disease Institute Virginia Mason Medical Center 1100 9th Ave., MS: C3-GAS Seattle, WA 98111 United States Fax: +1-206-223-6379 [email protected]
Department of Gastroenterology, Virginia Mason Medical Center, Seattle, Washington, United States Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, United States
Background and study aims: Nonstricture benign biliary diseases (BBDs) such as leaks, perforations, and bleeding, have been traditionally managed by placement of one or more plastic stents. Emerging data support the use of covered, self-expandable, metal stents (CSEMSs). The aim of this study was to assess the outcomes of endoscopic temporary placement of CSEMS in patients with nonstricture BBD. Patients and methods: This was a retrospective study of CSEMS placement for BBD between May 2005 and August 2013 at two tertiary care centers. The main outcome measures were resolution of perforation, bleeding, leak, and adverse events related to CSEMS treatment. Results: A total of 87 patients were included (median age 62 years [range 18 – 86]). Indications for stent placement were bile leaks (n = 35, 40 %),
bleeding (n = 27, 31 %), perforation (n = 18, 21 %), and other conditions (n = 7, 8 %). Fully and partially covered 8 – 10-mm diameter CSEMS were placed and subsequently removed in all 87 patients (100 %). Resolution of the underlying problem was achieved for 33 bile leaks (94 %), 25 bleedings (93 %), 18 perforations (100 %), and for 3 cases with other indications (43 %). The median duration of stenting was 9 weeks in patients with biliary leaks, 3 weeks for bleeding, and 9.5 weeks for perforations. Median follow-up was 82 weeks after stent removal. Seven adverse events occurred, including cholangitis in six patients (7 %), and tissue hyperplasia leading to difficulty in the removal of a partially covered SEMS in one patient. Conclusions: Nonstricture BBD can be effectively and safely treated with the short term placement of CSEMS.
Introduction
transpapillary plastic stents [4], biliary sphincterotomy alone [4], or a combination of the two, is the first-line treatment for biliary leaks [2, 4]. Recent data suggest a combination of biliary sphincterotomy and placement of a transpapillary biliary stent results in better outcomes for high grade bile leaks [2, 15]. Endoscopic management of bile leaks with plastic stents is safe and efficacious [2, 4, 16, 17]. However, difficult-to-treat, refractory bile leaks may require multiple endoscopic interventions or surgery [2, 4]. Complications of endoscopic sphincterotomy include bleeding [5, 18, 19] and perforation [18, 20]. Post-sphincterotomy bleeding rates vary from 0.76 % – 2 % to 10 % – 48 % [5, 19, 21], and can be immediate or delayed [5, 22, 23]. Endoscopic therapies include epinephrine injection, thermal therapy, balloon tamponade, clips, and placement of large-bore plastic stents (10 Fr or larger) to tamponade the bleeding site and to maintain biliary drainage [1, 15, 19]. Refractory bleeding may require angiographic embolization or surgery [5, 19]. There have been several reports of bleeding
!
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Plastic stents are used to treat benign biliary disease (BBD) [1], such as biliary leaks [2 – 4], postsphincterotomy bleeding [5], and iatrogenic perforations [6]. Self-expandable metal stents (SEMSs) were introduced to prolong stent patency by increasing the luminal diameter. Uncovered SEMSs embed into the bile duct making removal virtually impossible [1, 7, 8]. Covered SEMSs (CSEMSs) were introduced to prolong stent patency by reducing tissue ingrowth. Plastic stents are effective for most biliary leaks, bleeding, and perforations, but their limited diameters may fail to resolve the underlying disorder [9]. Advantages of CSEMSs over plastic stents include small pre-deployment and large post-expansion diameters, with the ability to close perforations and tamponade bleeding. In addition, CSEMSs do not embed and are removable [10 – 14]. Biliary leaks most commonly occur following laparoscopic cholecystectomy [2, 15]. Placement of
Irani Shayan et al. Covered, self-expandable, metal stents for biliary diseases … Endoscopy 2015; 47: 315–321
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Original article
encountered from varices and tumors invading the bile duct [9]. Post-sphincterotomy perforations occur in 0.35 % – 0.72 % of cases [6, 20]. Endoscopic placement of transpapillary plastic stents is efficacious in most cases and surgery is occasionally required [6, 20, 21]. CSEMSs have been used to effectively treat biliary leaks, perforations, and other biliary disorders, but data are limited [1, 9, 11, 24]. The aim of the current study was to report the outcome following placement of CSEMSs for the treatment of various nonstricture BBD.
Table 1 Patient characteristics and indications for placement of covered, self-expandable, metal stents in patients with nonstricture-related benign biliary disease (n = 87). Age, median (range), years
62 (18 – 86)
Sex, male/female, n
47/40
Weight, median (range), kg
71 (39 – 128)
Indication, n Biliary leak
35
Post-cholecystectomy
24
Abscess/pancreatic necrosis
10
Post EUS-biliary rendezvous Bleeding, n
Patients and methods
Post-sphincterotomy
!
Bile duct varices
Patients
Bleeding neuroendocrine tumor
The endoscopy and billing databases of two tertiary care medical centers (Virginia Mason Medical Center, Seattle and Mayo Clinic, Rochester) were reviewed from May 2005 to August 2013 to identify patients with nonstricture BBD who had undergone temporary placement of a CSEMS. Pre-procedural, procedural, and post-procedural details were recorded. Information was obtained via telephone contact with referring providers and review of outside records for patients who received follow-up at other institutions. The study was approved by the Institutional Review Boards of both institutions.
Stent placement procedure Written informed consent was obtained from all patients. Most procedures (60 %) were performed with the patient under moderate sedation. Endoscopists were experienced in biliary therapy (≥ 300 endoscopic retrograde cholangiopancreatographies [ERCPs] per year) and used standard video duodenoscopes (TJF140, 160, 180 series; Olympus America Inc., Center Valley, Pennsylvania, USA) for patients with conventional anatomy, and an adult colonoscope (CF-160, CF-180, Olympus America Inc.) for patients with biliary-enteric anastomoses. The previous use of plastic stents, including number and diameter, was recorded. Presence or absence of a gallbladder and relationship of the CSEMS to the cystic duct takeoff was noted. Duration of CSEMS placement was based on endoscopist recommendations and the patient’s ability to return. Planned CSEMS removal was 2 weeks after percutaneous drain removal for biliary leaks, 4 – 6 weeks for iatrogenic perforations, and 2 weeks for post-sphincterotomy bleeding. CSEMS removal was performed by grasping the stent with a standard polypectomy snare and either withdrawing the endoscope with the stent or withdrawing the stent through the instrument channel. Adverse events were recorded as those occurring during the CSEMS dwell period and those occurring at or within 30 days after CSEMS removal. Adverse events were defined and graded in severity according to accepted criteria [25]. Success was defined clinically and radiologically (at follow-up ERCP) and after removal of percutaneous drains, if present.
Results !
Indications for stent placement A total of 87 patients were identified (47 males, median age 62 years) who underwent CSEMS placement and removal for nonstricture BBD. Of these patients, 35 (40 %) had biliary leaks, 27
Perforation, n Post-sphincterotomy
1 27 23 3 1 18 12
Biliary-enteric anastomosis Other, n
6 7
Removal of partially covered SEMS
3
Facilitate biliary stone removal
2
Sump syndrome
1
Choledochogastric fistula
1
EUS, endoscopic ultrasound; SEMS, self-expandable metal stent.
(31 %) had bleeding, 18 (21 %) had perforations (12 post-sphincterotomy and 6 perforations associated with balloon dilation of biliary enteric anastomoses), and 7 patients (8 %) had other conditions. The latter included attempted removal of previously placed partially covered SEMSs at other institutions (n = 3), biliary stone removal (n = 2), sump syndrome (n = 1), and choledocho" Table 1). The outcome of the 35 patients gastric fistula (n = 1) (● with biliary leak has been reported previously [9]. Bile leaks (n = 35) occurred after cholecystectomy (n = 24), severe acute pancreatitis (n = 10), or after endoscopic ultrasound (EUS)biliary rendezvous (n = 1). Refractory bile leaks were defined by failure to respond (persistent high output from percutaneous drain or persistent leak at cholangiography) to a 10-Fr plastic stent and biliary sphincterotomy for more than 2 weeks (n = 25) " Fig. 1). Large bile leaks were defined by contrast extrava[2, 4] (● sation without filling the intrahepatic ducts (n = 9). In these nine cases, CSEMSs were placed as the initial endoscopic therapy as per the preference of the endoscopist because it was believed that plastic stent therapy was likely to fail. Successful resolution of the biliary leak was defined by removal of the percutaneous drain (after output from the drain dropped below 5 mL/day) with no recurrence for at least 4 weeks after CSEMS removal " Table 2). (● Refractory post-sphincterotomy bleeding (n = 23), defined as failure to respond to epinephrine injection and thermal therapy with or without hemostatic clips, was the most common cause " Fig. 2). Three patients had bile of bleeding from the bile duct (● duct variceal bleeding, and one patient had a bleeding pancreatic neuroendocrine tumor with recurrent hemobilia and cholangitis. Perforation (n = 18) was defined as presence of free or retroperitoneal air visualized fluoroscopically in addition to an obvious full-thickness defect and contrast extravasation at the sphincter" Fig. 3, otomy site (n = 12), or biliary-enteric anastomosis (n = 6) (● ●" Video 1). Miscellaneous disorders included: three cases of previously placed partially covered SEMSs (failure to remove at previous endoscopy); two cases in which CSEMS was used to facilitate
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large bile duct stone removal; one case of choledochogastric fistula, which resulted in recurrent cholangitis occurring after partial hepatectomy and chemoembolization for liver metastases; and one case of sump syndrome, defined as recurrent biliary obstruction caused by food, stones, or debris after choledochoenterostomy.
Outcomes of stent treatment Removability All CSEMSs were successfully removed. Removal was difficult in only one patient, who had received a partially covered SEMS (12/87 patients), through which tissue ingrowth had occurred; a second endoscopic procedure was required for removal of this stent.
Stent duration The median duration of stent placement was 9 weeks (range 2 – 115 weeks) for patients with bile leaks, 3 weeks (range 1 – 11 weeks) for patients with post-sphincterotomy bleeding, 9.5 weeks (range 4 – 14 weeks) for patients with perforations, and
Table 2
12 days for stent-in-stent removal of previously placed partially covered SEMSs. For patients with bleeding bile duct varices, a CSEMS was left in place for 18 and 12 months respectively in two patients, who later died from complications of metastatic pancreatic cancer. No recurrent bleeding occurred during the period of stent dwell. A third patient with inoperable serous cystadenoma of the pancreas required placement of two partially covered SEMSs during a total stent dwell time of 22 months. The fourth patient with recurrent cholangitis and hemobilia caused by a neuroendocrine tumor of the pancreatic head had no recurrence of bleeding following the stent placement 6 months pre" Table 3). viously (●
Resolution of underlying problem Bile leaks resolved in all but two of the 35 patients (6 %), with one patient dying from an infected biloma and the second patient requiring placement of an additional plastic stent into the cystic duct stump to facilitate leak resolution. Notably, in patients with post-cholecystectomy bile leaks, some CSEMSs were placed above the leak site and some below; only one patient, who had a
Site of bile leak (n = 35).
Site of bile leak
CSEMS above cystic duct
Cystic duct stump
CSEMS below cystic duct
Gallbladder
15
4
Absent
Gallbladder remnant
1
1
Remnant only
Duct of Luschka
3
0
Absent
Common bile duct
4
1
Absent
Common bile duct
0
6
Present
CSEMS, covered self-expandable metal stent.
Irani Shayan et al. Covered, self-expandable, metal stents for biliary diseases … Endoscopy 2015; 47: 315–321
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Fig. 1 Biliary leak. a Sphincterotomy and placement of a plastic stent was performed to treat the leak. b After 2 weeks of plastic stent therapy the leak has not resolved. c The site was treated successfully with a fully covered, self-expandable, metal stent placed above the level of the leak. d Complete resolution of the leak at endoscopic retrograde cholangiopancreatography 6 weeks later.
Original article
Fig. 2 Post-sphincterotomy bleeding. a Sphincterotomy performed for stone extraction. b Bleeding occurred 2 days later and failed to respond to epinephrine and thermal therapy. c, d A fully covered, self-expandable, metal stent was placed with successful resolution of bleeding. The stent remained in place for 10 days.
Fig. 3 Perforation. a Post-sphincterotomy perforation with retroperitoneal leakage of contrast (arrow) after balloon dilation and stone extraction. b Endoscopic view. c The perforation was successfully treated by placement of a fully covered, selfexpandable, metal stent for 5 weeks. d Endoscopic view.
bile leak and an intact gallbladder, had a CSEMS placed across the cystic duct, with no adverse events. In patients with bile leaks from the cystic duct or gallbladder, there was no difference in
stent dwell time when CSEMS were placed above the cystic duct (n = 16; median 6.5 weeks) or below the cystic duct (n = 5; median 8 weeks; P = 0.33).
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Table 3 Post-procedural details of patients undergoing covered self-expandable, metal stent placement in nonstricture-related benign biliary disease (n = 87). Prior plastic stent use, n (%)
32 (37)
Type of stent, n (%)
87
Wallstent (partially covered)
12 (14)
Table 4 Adverse events in patients undergoing covered self-expandable metal stent placement for nonstricture-related benign biliary disease (n = 87). During and after placement, n (%) Cholangitis At and after removal, n (%)
87 4 87
Wallflex (10 mm)
29 (33)
Cholangitis
2
Viabil
46 (53)
Tissue hyperplasia with difficulty removing SEMS
1
8 mm
11
10 mm
35
319
Unrelated deaths, n (%)
3
SEMS, self-expandable metal stent.
Biliary leak
9 (2 – 115)
Bleeding
3 (1 – 11)
Perforation
9.5 (4 – 14)
Resolution of underlying problem, n (%) Biliary leak
33/35 (94) 1
Bleeding
25/27 (93) 2
Perforation
18/18 (100)
Other indications
3/7 (43)
Removal of partially covered SEMS
2/3
Facilitate biliary stone removal
1/2
Sump syndrome
0/1
Choledochogastric fistula Follow-up after stent removal, median, weeks
0/1 82
SEMS, self-expandable metal stent. 1 One patient died from sepsis from infected biloma and another patient failed. 2 One patient re-bled after being restarted on Coumadin, and another while on clopidogrel.
Perforations successfully closed in all 18 patients (biliary-enteric anastomosis n = 6, post-sphincterotomy n = 12). Patients were hospitalized for a median of 2.5 days (range 1 – 12 days) after CSEMS placement and were treated with antibiotics for a median of 4 days (range 3 – 14 days). Four patients (post-sphincterotomy n = 3, biliary-enteric anastomosis n = 1) required temporary percutaneous drain placement for an infected fluid collection. The remaining patients (n = 14) did not require percutaneous or surgical intervention. In patients with post-sphincterotomy bleeding in whom endoscopic therapy with epinephrine injection and coaptive coagulation had failed, bleeding resolved immediately after CSEMS placement. Two patients required 2 and 3 units of packed red blood cells, respectively, before endoscopic treatment but none required transfusion after treatment. The two cases of treatment failure (with ongoing warfarin and clopidogrel use, respectively) were treated with repeat epinephrine injection, thermal therapy, and hemostatic clips, in addition to cessation of warfarin and clopidogrel treatment for 7 days.
Video 1
Retroperitoneal perforation and air in Online content including video sequences viewable the portal vein after initial attempt at: www.thieme-connect.de to remove a bile duct stone. The perforation was treated successfully at subsequent endoscopic retrograde cholangiopancreatography, with stone removal and placement of a fully covered, metal stent.
Fully covered SEMS placement to facilitate removal of previously placed partially covered SEMSs by using the stent-in-stent technique was successful in two of three patients. The fully covered SEMSs were removed easily in all three patients at 14 days (successful partially covered SEMS removal n = 2) and 7 days (unsuccessful partially covered SEMS removal), respectively. In the patient with sump syndrome (prior biliary sphincterotomy), recurrent cholangitis continued despite CSEMS placement and it was removed 74 days after insertion. Treatment in one of two patients in whom CSEMSs were placed to facilitate biliary stone clearance failed because severe cholangitis developed post-procedurally. Intensive care unit management and vasopressor support was administered and the stent was removed 4 days later. The other patient had choledocholithiasis in the setting of a benign distal bile duct stricture, which prevented stone extraction during previous ERCP. A fully covered SEMS was placed to facilitate stricture dilation with placement of two double-pigtail plastic stents through the CSEMS. Complete ductal clearance was achieved at the time of removal 43 days later.
Adverse events The median follow-up after stent removal was 82 weeks. Adverse " Table 4). Four patients events occurred in 7/87 patients (8 %) (● developed cholangitis during the period of stent placement. One case was mild and responded to outpatient oral antibiotics, two were moderate and required antibiotics and stent removal, and one was severe (mentioned above). Two additional patients developed cholangitis 24 hours after CSEMS removal; cholangitis was mild and was treated with antibiotics and 1 day in hospital in both cases. Asymptomatic tissue hyperplasia was noted at stent removal in three patients with partially covered SEMSs. In two, the CSEMSs were removed without sequelae. However, one patient required side-by-side, 10-Fr plastic stent placement and repeat endoscopy (moderate adverse event) for subsequent endoscopic removal. There were three patient deaths from unrelated causes (one while the CSEMS was in place) at a mean of 226 days after CSEMS placement. Causes of death included prostate cancer (n = 1) and pulmonary embolism (n = 1). The cause of death was unknown in one patient (death occurred 7 weeks after stent removal; care received at an outside facility).
Discussion !
CSEMSs were initially developed to prolong stent patency in malignant biliary obstruction [26], but they now play a role in the treatment of BBD [4, 11, 26 – 28]. The use of CSEMSs to treat refractory or large biliary leaks, bleeding, and perforations produced success rates of 93 % – 100 % in the current study, with minimal adverse events.
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Duration of stent placement, median (range), weeks
Original article
In a series of 13 patients with complex biliary leaks [24], all were successfully closed using fully covered SEMSs. Mucosal ulcerations noted on cholangioscopy at the time of stent removal may have been related to anchoring fins. De novo stricture formation was reported in two patients. However, in a more recent series of 25 patients [21] (refractory biliary leaks n = 17, bleeding n = 4, perforation n = 4), all patients responded to short-term placement of a fully covered SEMS (3 – 30 days), without adverse events. Three patients in the current series developed tissue hyperplasia associated with partially covered SEMSs, with one requiring an additional procedure to remove the CSEMS; however, none of these patients developed a de novo stricture after a median follow up of 32 months. Thus, we recommend against routine placement of partially covered SEMSs for benign disease, especially if the expected stent dwell time is longer than 4 weeks. In the same series of 13 patients [24], choledocholithiasis and/or luminal debris was noted in 10 patients at the time of stent removal compared with only 5 patients in the current series, all of whom were asymptomatic. The median duration of stent placement was 64 days in patients developing biliary debris. SEMSs covered with silicone and polyurethane may be less prone to biofilm formation than expanded polytetrafluoroethylene [13], and may be less likely to develop stone and sludge formation. However, reflux of gastroduodenal contents remains an issue [24]. Patients with refractory biliary leaks (despite sphincterotomy and 2 weeks of plastic stenting) and large biliary leaks were treated by CSEMS placement because of the larger diameter and the ability to “close off” the leak when placed proximal to the site of leakage. Alternatively, upsizing or placement of additional plastic stents could have been used. However, comparative data to guide this decision are lacking, and it must be made on an individual basis. In a series of five patients [29] with difficult-to-treat postsphincterotomy bleeding, temporary fully covered SEMSs were successfully placed for tamponade with a median stent dwell time of 4 weeks. More recently, four patients [21] achieved hemostasis with a median stent dwell time of 6 days (3 – 15 days). In the current study, failure occurred in 2/27 patients (7 %) and was believed to be due to ongoing use of antithrombotics. Both patients responded to further endoscopic therapy and the cessation of anticoagulation therapy for 7 days. The median stent dwell time was 21 days. Based on previous case series [21] and our own experience, we estimate 2 weeks of fully covered SEMS placement is adequate in this setting. In two patients, fully covered SEMSs were used to close perforations after endoscopic sphincterotomy [14]. Stents were removed after a mean dwell time of 96 days. Another four perforations [21] were medically managed without the need for surgery, and patients resumed oral feeding and were discharged within 7 days, with all stents removed within 30 days. All of the 18 patients with perforation in the current study were also successfully treated with CSEMSs (median stent dwell time 9.5 weeks) without the need for surgery, although four patients required percutaneous drainage. In this setting, CSEMS removal was performed 2 – 4 weeks after removal of the percutaneous drainage catheter. This stent dwell time is between those of the two previous case series [14, 21], but we believe that 4 – 6 weeks would be adequate in this setting. The stent-in-stent technique of placing a fully covered SEMS inside an embedded partially covered SEMS for 7 – 14 days to induce pressure necrosis of intervening tissue to allow subsequent removal of esophageal stents [30] has been used to remove un-
covered biliary SEMS in two patients [31, 32]. In the current study, this technique failed in one patient; stent removal was attempted only 7 days after placement of the fully covered SEMS, and a longer dwell time may have been more successful. In fact, the partially covered SEMS was finally removed after 3 months of treatment with multiple plastic stents. Partially covered SEMSs were easily removed in the current series, especially when they extended into the duodenum because only the 5-mm proximal uncovered portion becomes embedded [33]. However, grossly evident luminal occlusion and tissue hyperplasia occurred in three patients with partially covered SEMSs. In contrast, all fully covered SEMSs were easily removed, consistent with previous publications [3]. We suggest partially covered SEMSs should not be used routinely for BBD [34]. Limitations of this study include the retrospective design and the lack of a control group. Consequently the routine use of CSEMSs for treatment of all BBDs cannot be recommended based on the current results. The length of follow-up after stent removal was also relatively short (82 weeks). However, this is the largest series to investigate the management of such patients with CSEMS. In conclusion, CSEMSs are safe and effective for treating nonstricture-related BBDs, especially after failed plastic stent therapy. The cost of CSEMS (range $ 1000 – 1800) is a potential disadvantage compared with plastic stents (range $ 5 – 10). In addition, iatrogenic, proximal strictures may occur after CSEMS placement, especially when there is stent– duct size discordance [35]. This potential complication combined with the risk of sludge and stone formation, and reflux of gastroduodenal contents, should prompt the removal of CSEMS as soon as the underlying problem is resolved. While fully covered SEMSs appear to induce fewer adverse events than partially covered SEMSs, a definite advantage of CSEMSs over plastic stents as primary therapy for benign biliary disorders remains unproven. Competing interests: Virginia Mason Medical Center receives restricted funding for educational purposes from Boston Scientific (BSCI), Cook Medical, and Olympus America Inc. Dr. Baron has received research funding from BSCI.
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