Fully covered metal biliary stents: A review of the literature

Fully covered self-expandable metal stents (FCSEMS) represent the latest advancement of metal biliary stents used to endoscopically treat a variety of obstructive biliary pathology. A large stent diameter and synthetic covering over the tubular mesh prolong stent patency and reduce risk for tissue hyperplasia and tumor ingrowth. Additionally, FCSEMS can be easily removed. All these features address issues faced by plastic and uncovered metal stents. The purpose of this paper is to comprehensively review the application of FCSEMS in benign and malignant biliary strictures, biliary leak, and post-sphincterotomy bleeding.     

Fully-covered, self-expandable metal stents (CSEMS) in malignant distal biliary strictures: mid-term evaluation

Background and Aims: Limited data exist regarding fully‐covered, self‐expandable metal stents (CSEMS) with anchoring fins for the management of malignant distal biliary strictures. The aim of this study is to evaluate their safety and patency. Methods: Over a period of 2 years, 70 patients (45 males, 66 ± 13 years) underwent endoscopic retrograde cholangiopancreatography (ERCP) with placement of a 10‐mm (67 patients) or 8‐mm diameter (3 patients) CSEMS for the palliation of distal malignant biliary obstruction (pancreatic [53] or other [17]). Data were collected prospectively for survival and stent patency; complications were evaluated retrospectively. Results: After CSEMS placement, 17 patients proceeded to surgery, and 53 patients were deemed unresectable. Mean survival for non‐surgical candidates was 180 days (range: 15–1091), and 170 days (range: 9–589) for patients who underwent surgical management. CSEMS were left in place and remained patent for a mean of 163 days (range: 15–1091) in non‐surgical candidates, and a mean of 55 days (range: 5–126) in surgical candidates. Complications during placement included wire perforations (4) and proximal deployment requiring repositioning (4), one of which was complicated by a bile leak. Post‐procedure complications were observed in 24 cases (34%) and included post‐ERCP pancreatitis (8, with 2 of them severe), post‐procedure pain (5, with 3 requiring admission), cholecystitis (3), stent occlusion (3), cholangitis (2), proximal migration (1), post‐sphincterotomy bleeding (1), and sepsis leading to death (1). Conclusion: CSEMS appear to provide acceptable short‐term patency rates; however, their limited long‐term patency and high complication rate might limit their widespread use. Further long‐term prospective data are required to confirm this observation.     

Endoscopic Treatment of Benign Biliary Strictures Using Covered Self-Expandable Metal Stents (CSEMS)

Background and Aims

Traditional endoscopic management of benign biliary strictures (BBS) consists of placement of one or more plastic stents. Emerging data support the use of covered self-expandable metal stents (CSEMS). We sought to assess outcome of endoscopic temporary placement of CSEMS in patients with BBS.

Methods

This was a retrospective study of CSEMS placement for BBS between May 2005 and July 2012 from two tertiary care centers. A total of 145 patients (81 males, median age 59 years) with BBS were identified; 73 of which were classified as extrinsic and were caused by chronic pancreatitis, and 70 were intrinsic. Main outcome measures were resolution of stricture and adverse events (AEs) due to self-expandable metal stents (SEMS)-related therapy.

Results

Fully covered and partially covered 8–10 mm diameter SEMS were placed and subsequently removed in 121/125 (97 %) attempts in BBS (failure to remove four partially covered stents). Stricture resolution occurred in 83/125 (66 %) patients after a median stent duration of 26 weeks (median follow-up 90 weeks). Resolution of extrinsic strictures was significantly lower compared to intrinsic strictures (31/65, 48 % vs. 52/60, 87 %, p = 0.004) despite longer median stent duration (30 vs. 20 weeks). Thirty-seven AEs occurred in 25 patients (17 %), with 12 developing multiple AEs including cholangitis (n = 17), pancreatitis (n = 5), proximal stent migration (n = 3), cholecystitis (n = 2), pain requiring SEMS removal and/or hospitalization (n = 3), inability to remove (n = 4), and new stricture formation (n = 3).

Conclusions

Benign biliary strictures can be effectively treated with CSEMS. Successful resolution of biliary strictures due to extrinsic disease is seen significantly less often than those due to intrinsic disease. Removal is successful in all patients with fully covered SEMS.     

Self Expandable Metal Stents for Anastomotic Stricture Following Liver Transplant

Background

Endoscopic treatment for biliary strictures with plastic stent placement has been used widely. The use of covered self-expandable metal stents (CSEMS) has been reported in anastomotic strictures post liver transplant. The aim of this study was to evaluate the efficacy of different CSEMS in these subjects.

Methods

A total of 55 patients with anastomotic stricture received CSEMS, which were removed after 3–4 months. There were 19 patients in group A (partially covered SEMS), 21 patients in group B (fully covered SEMS with fins) and 15 patients in group C (fully covered SEMS with flared ends). Technical success, stricture resolution, follows up, and complications were documented.

Results

CSEMS were successfully deployed in all 55 cases. There was no evidence of significant difference with regards to stricture resolution (14 [74 %] vs. 15 [71 %] vs. 9 [60 %] p = 0.6630, df = 2) or complications between groups. Stent-related complications were as follows: three in group A (2 migration, 1 occlusion), five in group B (4 occlusions, 1 migration), and one proximal migration in group C (p = 0.3894, df = 2). Three cases required surgery (hepatico-jejunostomy) due to refractory strictures.

Conclusions

The observed clinical success rate of CSEMS (70.4 %) proved to be below the reported one for multiple plastic stents, while no significant differences between CSEMS types were observed.     

Temporary placement of covered self-expandable metal stents in benign biliary strictures: a new paradigm? (with video)

BACKGROUND: Benign biliary strictures (BBS) are usually managed with plastic stents, whereas placement of uncovered metallic stents has been associated with failure related to mucosal hyperplasia. OBJECTIVE: We analyzed the efficacy and safety of temporary placement of a covered self-expanding metal stent (CSEMS) in BBS. DESIGN: Patients with BBS received temporary placement of CSEMSs until adequate drainage was achieved; confirmed by resolution of symptoms, normalization of liver function tests, and imaging. SETTING: Tertiary-care center with long-standing experience with CSEMSs. PATIENTS: Seventy-nine patients with BBS secondary to chronic pancreatitis (32), calculi (24), liver transplant (16), postoperative biliary repair (3), autoimmune pancreatitis (3), and primary sclerosing cholangitis (1). INTERVENTION: ERCP with temporary CSEMS placement. Removal of CSEMSs was performed with a snare or a rat-tooth forceps. MAIN OUTCOME MEASUREMENTS: End points were efficacy, morbidity, and clinical response. RESULTS: CSEMSs were removed from 65 patients. Resolution of the BBS was confirmed in 59 of 65 patients (90%) after a median follow-up of 12 months after removal (range 3-26 months). If patients who were lost to follow-up, developed cancer, or expired were considered failures, then an intent-to-treat global success rate of 59 of 79 (75%) was obtained. Complications associated with placement included 3 post-ERCP pancreatitis (4%), 1 postsphincterotomy bleed (1%), and 2 pain that required CSEMS removal (2%). In 11 patients (14%), the CSEMS migrated. In 1 patient, CSEMS removal was complicated by a bile leak that was successfully managed with plastic stents. LIMITATION: Pilot study from a single center. CONCLUSIONS: Temporary CSEMS placement in patients with BBS offers a potential alternative to surgery.     

Removal of self-expandable metallic Wallstents

BACKGROUND: The self-expandable metallic stent is increasingly being used for management of malignant biliary strictures. In certain clinical situations, it also may be an alternative treatment for benign strictures. The ability to remove a metallic stent would be advantageous to the management of many biliary strictures, regardless of etiology. METHODS: Stent removal was considered in 18 patients with either covered or uncovered Wallstents placed for biliary obstruction. Indications for placement were the following: unresectable cancer (10), chronic pancreatitis (3), benign biliary stricture (3), impacted stone (1), and papillary adenoma (1). OBSERVATIONS: Stent removal was successful in 17 patients. Mean follow-up after removal was 9 months. Thirteen removed stents were covered. Indications for removal were the following: occlusion (5), migration (3), facilitation of hemostasis (2), malposition (3), persistent cholestasis (1), stone extraction (1), stricture revision (1), gallbladder fossa abscess (1), and abdominal pain (1). Devices and techniques used for successful removal included a snare, an extraction balloon, and electrocoagulation combined with forceps. CONCLUSIONS: Removal of uncovered Wallstents is difficult and typically requires a combination of techniques. Removal of covered Wallstents with a snare is relatively simple and safe, and can be followed immediately by corrective therapy. Insertion of a covered Wallstent should be considered as initial therapy when malignant biliary obstruction is suspected but unconfirmed.     

全覆膜金属支架治疗良性胆道狭窄的初步研究

目的探讨全覆膜胆道金属支架治疗良性胆道狭窄的安全性及其疗效。方法36例良性胆道狭窄患者行全覆膜胆道金属支架置入术治疗,术后每1～2个月接受1次门诊随访,观察并发症发生及胆道狭窄改变情况。结果36例均一次性成功置入全覆膜胆道金属支架,未出现与操作相关的严重并发症,支架放置3～6个月后全部成功拔除,其中28例（77．8％）良性胆道狭窄消失。结论置入全覆膜胆道金属支架治疗良性胆道狭窄是安全的,近期疗效显著。     

ENDOSCOPIC MANAGEMENT OF PANCREATICO‐BILIARY STRICTURES: A MALAYSIAN EXPERIENCE

Three thousand one hundred and thirty‐seven endoscopic retrograde cholangiopancreatography procedures were carried out over a 10‐year period from 1993 to 2003. Two thousand three hundred and seventeen (73.9%) procedures were first attempt procedures, and 516 (22.2%) cases were performed for malignant biliary strictures. The majority of tumors were distally located (43.4%) followed by hilar or subhilar strictures (34.5%). Endoscopic retrograde cholangiopancreatography (ERCP) was performed in 35 patients with non‐malignant biliary strictures: 12 were due to chronic pancreatitis and 13 due to postoperative damage one, tuberculous stricture four were benign strictures with no obvious cause, four cases of primary sclerosing cholangitis, and one case of Caroli's disease. Of 936 patients with biliary stone disease, 63 (6.7%) patients had strictures of varying degree and extent. ERCP was performed in only 12 cases of benign pancreatic strictures. Biliary stricture due to tuberculosis was distinctly uncommon and only one case was reported. Pre‐cutting with needle‐knife was used successfully in 27.0% of first attempts at common bile duct (CBD) cannulation. Overall, the use of needle knife precutting facilitated cannulation of the CBD in 159/435 (36.6%) (first and second attempts combined). The overwhelming majority of stents placed were polyethylene stents. Metallic self‐expandable stents were used only in a limited number of patients. Cytology brushings of biliary strictures were infrequently carried out. Multiple polyethylene stents were placed across benign strictures as a dilatation device for up to 12 months. Our experience with long‐term follow‐up (mean 7.7 years) of nine patients following for postoperative benign strictures has demonstrated excellent results with this management approach.     

Endoscopic stenting for biliary strictures.

A consensus is growing among units that have an experience in both endoscopic and percutaneous stenting techniques that the endoscopic approach of malignant biliary strictures is more comfortable for the patient and provides less complications. This article describes endoscopic biliary drainage in different malignant stenosis of the bile ducts and delineates the respective indications of percutaneous and endoscopic techniques together with the possible combination of these two methods in selected cases. It also tackles the question of the medical surgical approach of the patients, which might, thanks to a better selection, reduce the morbidity and mortality associated with surgery. The indications of biliary stenting in benign strictures, namely post operative or chronic pancreatitis associated biliary stenoses, are also discussed. Recently, new materials became available for endoscopic and percutaneous biliary drainage, and particularly metallic self expanding stents which might provide a better palliation among these patients. If these stents fulfill their promise on longer follow-up, they may replace the conventional stenting devices.     

Benign biliary strictures related to chronic pancreatitis: Balloons,stents, or surgery

Opinion statement Benign biliary strictures are seen in a subset of patients with chronic pancreatitis. Most patients are asymptomatic and require no intervention. In some patients, benign strictures can become symptomatic. In these patients, the aim of biliary drainage is to prevent long-term complications such as recurrent cholangitis and secondary biliary cirrhosis. The possibility of a malignant stricture should always be excluded. Successful endoscopic drainage of biliary obstruction has no influence on pain pattern in patients with chronic pancreatitis. At the first diagnosis of a symptomatic biliary stricture due to chronic pancreatitis, a polyethylene stent can be inserted endoscopically. If the stricture is still present despite stent exchange with serial insertion of multiple stents every 3 months for 1 year, surgery is indicated as definitive treatment. The role of self-expandable metal stents in the management of benign biliary strictures due to chronic pancreatitis is unclear, but they may be useful for nonoperative candidates and a select group of patients in whom surgery is planned. The aim of surgical therapy is to definitively treat the benign biliary stricture, especially in younger patients, who presumably have a longer lifespan.     

Malignant obstructive jaundice: the role of percutaneous metallic stents

OBJECTIVES: Efficiency evaluation of percutaneous metallic stents in palliative treatment of malignant biliary obstruction. METHODS: One hundred sixteen percutaneous metallic stents were implanted in 80 patients with malignant biliary obstruction. Thirty-five patients had hilar obstruction, 32 patients obstruction of the common bile duct and 12 patients obstruction of a bilioenteric anastomosis. RESULTS: Adequate biliary drainage was achieved in 79 patients. Early complications occurred in 23.75% of patients; 12.5% of patients died within 30 days. The procedure-related mortality rate was 5%; 18.75% of patients showed recurrent jaundice after an average of 175 days. CONCLUSION: Percutaneous metallic stents are an efficient means of treating malignant biliary strictures, particularly of upper biliary obstructions. However, this treatment has risks and limits that require careful patient recruitment.     

Should a fully covered self-expandable biliary metal stent be anchored with a double-pigtail plastic stent? A retrospective study

BACKGROUND The migration rate of fully covered self-expandable metal stents(FCSEMSs) has been reported to be between 14% to 37%. Anchoring of FCSEMSs using a doublepigtail plastic stent(DPS) may decrease migration.AIM To compare stent migration rates between patients who received FCSEMS alone and those who received both an FCSEMS and anchoring DPS.METHODS We conducted a retrospective analysis of endoscopy reporting system and medical records of 1366 patients who underwent endoscopic retrograde cholangiopancreatography(ERCP) with FCSEMS placement at the University of Kentucky health care. Between July 2015 and April 2017,203 patients with FCSEMS insertion for the treatment of malignant biliary stricture,benign biliary stricture,post-sphincterotomy bleeding,bile leak,and cholangitis drainage were identified. The review and analysis were conducted through our endoscopy reporting system(ProVation~? MD) and medical records. Categorical data were analyzed using Chi-Square and Fischer exact test and continuous data using nonparametric tests. A regression analysis was performed to identify factors independently associated with increased risk of stent migration. We determinedan FCSEMS migration endoscopically if the stent was no longer visible in the major papilla.RESULTS1366 patients had undergone ERCP by three advanced endoscopists over 21-mo period; among these,203 patients had FCSEMSs placed. 65 patients had FCSEMSs with DPS,and 138 had FCSEMSs alone. 65 patients had FCSEMSs with DPS,and 138 had FCSEMSs alone. 95 patients had a malignant stricture,82 patients had a benign stricture,12 patients had bile leak,12 patients had cholangitis,and nine patients had post-sphincterotomy bleeding. The migration rate in patients with anchored FCSEMSs with DPS was 6%,and those without anchoring DPS was 10%(P = 0.35). Overall,migration was reported in 18 patients with FCSEMSs placement out of 203 patients with an overall migration rate of 9.7%. There was no significant association between anchoring the FCSEMSs with DPS and the risk of stent migration. Only patients with the previous sphincterotomy and begin biliary stricture were found to have a statistically significant difference in the migration rate between patients who had FCSEMS with DPS and FCSEMS alone(P = 0.01).CONCLUSION The risk of migration of biliary FCSEMS was 9.7 %. Anchoring an FCSEMS with DPS does not decrease the risk of stent migration.     

Prospective evaluation of the partially covered nitinol “ComVi” stent for malignant non hilar biliary obstruction

BackgroundBiliary partially covered self-expandable metal stents (PC-SEMS) offer prolonged relief of symptoms of biliary obstruction but may induce complications including pancreatitis, cholecystitis and migration.AimsTo assess efficacy and safety of the ComVi partially covered self-expandable metal stents as primary palliative treatment of distal malignant biliary obstruction.MethodsSeventy patients (mean age 69.2 years) with distal malignant biliary strictures were prospectively included and underwent endoscopic retrograde cholangio-pancreatography and partially covered self-expandable metal stents placement. Follow-up was done for 12 months. self-expandable metal stents patency, survival and complication-rate after partially covered self-expandable metal stents placement were evaluated.ResultsOverall median survival time was 190 days (30–856). Forty-four patients (62.8%) died after median 175.5 days (30–614) without signs of stent dysfunction; 37 patients (52.8%) were alive after 6 months without signs of self-expandable metal stents occlusion. Survival rapidly dropped between 8 and 12 months after treatment. Survival was not influenced by sex (P = 0.1) or type of neoplasia (P = 0.178). Median survival was longer (254 days [44–836]) in patients who underwent chemotherapy (P < 0.0001). Partially covered self-expandable metal stents occlusion had 24 (35.7%) patients 154 days (35–485) after treatment. Median survival after re-treatment was 66 days (13–597). Cholecystitis occurred in one patient (1.7%).ConclusionsThe ComVi partially covered self-expandable metal stents is effective for palliation of biliary obstruction secondary to distal malignant biliary strictures. Self-expandable metal stents patency during follow-up is satisfactory without significant complications.     

Comparison between uncovered and covered self-expandable metal stent placement in malignant duodenal obstruction

AIM:To compare the clinical outcomes of uncovered and covered self-expandable metal stent placements in patients with malignant duodenal obstruction.METHODS:A total of 67 patients were retrospectivelyenrolled from January 2003 to June 2013.All patients had symptomatic obstruction characterized by nausea,vomiting,reduced oral intake,and weight loss.The exclusion criteria included asymptomatic duodenal obstruction,perforation or peritonitis,concomitant small bowel obstruction,or duodenal obstruction caused by benign strictures.The technical and clinical success rate,complication rate,and stent patency were compared according to the placement of uncovered(n = 38) or covered(n = 29) stents.RESULTS:The technical and clinical success rates did not differ between the uncovered and covered stent groups(100% vs 96.6% and 89.5% vs 82.8%).There were no differences in the overall complication rates between the uncovered and covered stent groups(31.6% vs 41.4%).However,stent migration occurred more frequently with covered than uncovered stents [20.7%(6/29) vs 0%(0/38),P < 0.05].Moreover,the overall cumulative median duration of stent patency was longer in uncovered than in covered stents [251 d(95%CI:149.8 d-352.2 d) vs 139 d(95%CI:45.5 d-232.5 d),P < 0.05 by log-rank test] The overall cumulative median survival period was not different between the uncovered stent(70 d) and covered stent groups(60 d).CONCLUSION:Uncovered stents may be preferable in malignant duodenal obstruction because of their greater resistance to stent migration and longer stent patency than covered stents.     

Endoscopic management of hilar biliary strictures

Hilar biliary strictures are caused by various benign and malignant conditions. It is difficult to differentiate benign and malignant strictures. Postcholecystectomy benign biliary strictures are frequently encountered. Endoscopic management of these strictures is challenging. An endoscopic method has been advocated that involves placement of increasing number of stents at regular intervals to resolve the stricture. Malignant hilar strictures are mostly unresectable at the time of diagnosis and only palliation is possible.Endoscopic palliation is preferred over surgery or radiological intervention. Magnetic resonance cholangiopancreaticography is quite important in the management of these strictures. Metal stents are superior to plastic stents. The opinion is divided over the issue of unilateral or bilateral stenting.Minimal contrast or no contrast technique has been advocated during endoscopic retrograde cholangiopancreatography of these patients. The role of intraluminal brachytherapy, intraductal ablation devices, photodynamic therapy, and endoscopic ultrasound still remains to be defined.     

Novel biliary self-expanding metal stents: indications and applications

Endoscopic insertion of a self-expanding metal stent (SEMS) through a malignant common bile duct stricture is the first line of palliation for malignant jaundice. Patency of these stents remains a major concern. SEMS dysfunction can result from tumor ingrowth, overgrowth and/or clogging. Initial SEMS modifications involved covering the central part of the stent in order to reduce ingrowth and ultimately increase patency. Fully covered stents became available shortly after reports of their use in human patients. The potential removability and radial strength of SEMS have led to evaluation of their use in new indications including benign biliary strictures, post sphincterotomy bleeding and perforation. Other aspects of development include the addition of features such as anti-reflux valves, drug elution and spontaneous biodegradability. These aspects and their clinical implications are reviewed and discussed.     

Endoscopic biliary stenting in a district general hospital.

During a 48 month period to December 1990, 367 patients, median age 75 years, with obstructive jaundice caused by common bile duct stones (201), malignant biliary obstruction (148), and benign biliary strictures (18), underwent therapeutic endoscopic retrograde cholangiopancreatography. Endoscopic biliary stenting and drainage was achieved in 343 of 367 patients attempted (93%), seven patients requiring a combined percutaneous endoscopic approach. Endoscopic stenting failed in 24 patients because of malignant duodenal infiltration (10), Billroth 2 gastrectomy (6), tight and extensive biliary strictures (6), peripapillary diverticulum (1), and technical failure (1). Prolonged follow up was available in 91% (311 of 343). The 30 day mortality was 5% (17 of 343), which included two procedure related deaths (0.6%) from fulminant pancreatitis and major sphincterotomy site bleeding. Early complications occurred in 14% (48 of 343) and late complications occurred in 11.9% (35 of 294) patients, as of the original 343, 17 had died within 30 days and another 32 were lost to follow up. Eighty patients with incomplete bile duct clearance and eight patients with benign biliary strictures had biliary stents inserted for 12-48 months (median 30). Endoscopic biliary stenting services are necessary in a district general hospital with technical success, death and morbidity rates comparable to other studies.     

Self-expanding metallic stents in benign postoperative biliary strictures: a difficult surgical obstacle?

BACKGROUND/AIMS: To report the hazards of surgical management in patients suffering from benign postoperative biliary strictures (BBS) previously treated with self-expanding metallic stents (SEMS). METHODOLOGY: Five patients with BBS were treated by SEMS (Wallstent in 3 patients and Gianturco stent in 2) through an endoscopic (2 patients) or a percutaneous transhepatic route (3 patients). Metallic stent obstruction due to intraprosthetic epithelial hyperplasia was observed in all patients, being responsible for severe cholangitis and intrahepatic stones in 3 and 2 patients respectively. RESULTS: One patient remains free of symptoms but presented with right posterior liver atrophy. Difficult biliary repair was encountered in 3 patients, requiring excision and reconstruction of the main biliary convergence for severely damaged biliary wall and epithelium by metallic stents. One patient with a SEMS extended upward the right secondary biliary divisions required a right hemihepatectomy. CONCLUSIONS: The surgical management of benign biliary strictures is severely complicated by the presence of metallic stents. Thus, SEMS should not be employed for treating BBS in healthy patients with a low operative risk.     

Role of endoscopic retrograde cholangiopancreatography in the management of benign biliary strictures: What's new?

Benign biliary strictures comprise a heterogeneous group of diseases. The most common strictures amenable to endoscopic treatment are post-cholecystectomy, post-liver transplantation, related to primary sclerosing cholangitis and to chronic pancreatitis. Endoscopic treatment of benign biliary strictures is widely used as first line therapy, since it is effective, safe, noninvasive and repeatable. Endoscopic techniques currently used are dilation, multiple plastic stents insertion and fully covered self-expandable metal stents. The main indication for dilation alone is primary sclerosing cholangitis related strictures. In the vast majority of the remaining cases, temporary placement of multiple plastic stents with/without dilation is considered the treatment of choice. Although this approach is effective, it requires multiple endoscopic sessions due to the short duration of stent patency. Fully covered self-expandable metal stents appear as a good alternative to plastic stents, since they have an increased radial diameter, longer stent patency, easier insertion technique and similar efficacy. Recent advances in endoscopic technique and various devices have allowed successful treatment in most cases. The development of novel endoscopic techniques and devices is still ongoing.     

Post-cholecystectomy biliary strictures: Not always benign

Background:  Post-cholecystectomy malignant biliary obstruction masquerading as benign biliary stricture (BBS) has not been reported in the literature; it presents a diagnostic and management challenge.
Methods:  Of the 349 post-cholecystectomy BBS managed at a tertiary care hospital in northern India between 1989 and 2004, 11 patients were found to have biliary malignancy. Records of these 11 patients were analyzed retrospectively for the purpose of this study.
Results:  Mean age of patients with malignant biliary strictures was significantly higher (52 vs 38 years, P  = 0.000); they were more likely to have jaundice (100% vs 78%, P  = 0.008) and pruritus (82% vs 48%, P  = 0.03). Unlike most patients with BBS referred from elsewhere to us, they had had a smooth postoperative course uncomplicated by bile leak, had a longer cholecystectomy-presentation interval, and were more likely to have high strictures ((Bismuth type III/IV) 91% vs 49%, P  = 0.008).
Conclusions:  Post-cholecystectomy biliary obstruction is not always benign. High bilirubin levels and hilar strictures, especially after an uneventful cholecystectomy, in a middle-aged patient should raise a suspicion of underlying missed malignancy.