Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures

Not Applicable

Completed

Brief Summary: The current standard of care for benign bile duct strictures involves placement of multiple plastic stents under endoscopic and fluoroscopic guidance to progressively dilate or stretch it open. This approach necessitates multiple procedures which may extend over one year before the stricture is adequately dilated. The investigators propose a study comparing the standard approach of plastic stenting with the use of newer, fully coated metallic stents which are self-expandable, thereby permitting successful dilation of benign bile duct strictures with fewer procedures.

Detailed Description: Randomization, as detailed below, is stratified by etiology of the stricture: chronic pancreatitis and postoperative (such as post-liver transplant).

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Suspected malignant etiology for the stricture
Prior endotherapy within one year of presentation,except in the following two scenarios: 1) Early (< 30 days) stent placement following liver transplant; 2) in patients with chronic pancreatitis, single plastic stent placed during presenting ERCP while evaluating for malignancy
Bismuth Type II-IV stricture
Proximal common hepatic duct diameter < 6 mm
Intact gallbladder, except in cases where a stent can be deployed > 1cm below the cystic duct insertion
Age < 18 years, pregnancy, incarceration, inability to provide informed consent
Karnofsky score ≤ 40
Inability to pass a guidewire proximal to the stricture
Stricture > 8cm in length
Life expectancy < 1 year
Concomitant nonanastomotic biliary strictures or biliary casts

Arm && Interventions

Group	Intervention	Description
Fully Covered Metallic Stent	Fully covered Metallic Stent	Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.
Plastic Stent	Plastic Stent	Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria (details below).

Primary Outcome Measures

Name	Time	Method
Early Clinical Success	Post-stent removal (up to one year after enrollment)	Early clinical success will be defined as fluoroscopic resolution at the time all stent(s) are removed. If there is a persistent stricture after 12 months of stent therapy in either group, the patient will be classified as a clinical failure. We will compare early clinical success rates in each group.

Secondary Outcome Measures

Name	Time	Method

Locations (8): University of Chicago
🇺🇸
Chicago, Illinois, United States
Digestive Health Associates of Texas
🇺🇸
Dallas, Texas, United States
Royal Wolverhampton NHS Trust
🇬🇧
Wolverhampton, United Kingdom
Indiana University
🇺🇸
Indianapolis, Indiana, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Washington University in St. Louis
🇺🇸
Saint Louis, Missouri, United States