Evaluation of Sequential Stent Addition vs. Incremental Dilation & Stent Exchange for Management of Anastomotic Biliary Strictures After Liver Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Stanford University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Anastomotic biliary stricture resolution
Study Overview
Brief Summary
Prospective, randomized comparison of the incremental dilation and stent exchange vs. sequential stent addition approaches for management of anastomotic biliary strictures will facilitate optimal management of patients who develop anastomotic biliary strictures after liver transplantation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 and older
- •Clinical concern for anastomotic biliary stricture following liver transplantation (as determined by the referring transplant hepatologist)
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Exclusion Criteria
- •Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
- •Complex post-surgical anatomy e.g. Choledochojejunostomy, Billroth type II anatomy, Roux-en-Y-gastrojejunostomy
- •Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
- •Other biliary process which accounts for patient's abnormal liver function studies/imaging (i.e. significant non-anastomotic biliary stricture).
Arms & Interventions
Sequential stent addition
ERCP with sphincterotomy and stent placement is initially performed, then additional stents are placed across the stricture during sequential ERCPs, without stent removal/exchange or stricture dilation.
Intervention: Protocol for increasing number of stents across the anastomosis (Procedure)
Incremental Dilation & Stent Exchange
ERCP with sphincterotomy and stent placement is initially performed, with subsequent ERCPs involving removal of previously placed stents, stricture dilation and balloon sweeps to extract stone debris/sludge.
Intervention: Protocol for increasing number of stents across the anastomosis (Procedure)
Outcomes
Primary Outcomes
Anastomotic biliary stricture resolution
Time Frame: Immediately following final ERCP with stent removal
Fluoroscopic (on ERCP image) resolution of stricture at the time of final study ERCP when all stents are removed
Secondary Outcomes
- Fluoroscopy Parameters(1 day)
- Adverse Events(1 week)
- Sustained resolution of anastomotic stricture for 6 months(6 months after final study ERCP with stent removal)
- Sustained resolution of anastomotic stricture for 12 months(12 months after final study ERCP with stent removal)
Investigators
Subhas Banerjee
Associate Professor of Medicine, Division of Gastroenterology
Stanford University