Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures
- Conditions
- Common Bile Duct Stricture
- Registration Number
- NCT01221311
- Lead Sponsor
- Medical University of South Carolina
- 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
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- Bismuth Type I benign bile duct stricture
- Objective signs/symptoms related to the stricture
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Trial Locations
- Locations (8)
University of Chicago
🇺🇸Chicago, Illinois, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Digestive Health Associates of Texas
🇺🇸Dallas, Texas, United States
Royal Wolverhampton NHS Trust
🇬🇧Wolverhampton, United Kingdom
University of Chicago🇺🇸Chicago, Illinois, United States