Status:
UNKNOWN
Evaluation of Sequential Stent Addition vs. Incremental Dilation & Stent Exchange for Management of Anastomotic Biliary Strictures After Liver Transplantation
Lead Sponsor:
Stanford University
Collaborating Sponsors:
University of Rochester
University of Barcelona
Conditions:
Anastomotic Stenosis
Biliary Stricture
Eligibility:
All Genders
18+ years
Phase:
NA
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 mana...
Eligibility Criteria
Inclusion
- 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
- Age \<18
- 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).
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03229655
Start Date
September 1 2017
End Date
September 1 2022
Last Update
September 11 2018
Active Locations (1)
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1
Stanford University Medical Center
Stanford, California, United States, 94305