Status:
COMPLETED
Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
American Society for Gastrointestinal Endoscopy
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Common Bile Duct Stricture
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
Detailed Description
Randomization, as detailed below, is stratified by etiology of the stricture: chronic pancreatitis and postoperative (such as post-liver transplant).
Eligibility Criteria
Inclusion
- Bismuth Type I benign bile duct stricture
- Objective signs/symptoms related to the stricture
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT01221311
Start Date
January 1 2011
End Date
October 1 2016
Last Update
June 2 2017
Active Locations (8)
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1
University of Chicago
Chicago, Illinois, United States
2
Indiana University
Indianapolis, Indiana, United States, 46202
3
University of Michigan
Ann Arbor, Michigan, United States
4
Washington University in St. Louis
St Louis, Missouri, United States, 63108