Biliary Stricture Clinical Trial
Official title:
Evaluation of Sequential Stent Addition vs. Incremental Dilation & Stent Exchange for Management of Anastomotic Biliary Strictures After Liver Transplantation
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age 18 and older 2. Clinical concern for anastomotic biliary stricture following liver transplantation (as determined by the referring transplant hepatologist) 3. Willing and able to comply with the study procedures and provide written informed consent to participate in the study. Exclusion Criteria: 1. Age <18 2. Potentially vulnerable subjects including, homeless people, pregnant females, employees and students. 3. Complex post-surgical anatomy e.g. Choledochojejunostomy, Billroth type II anatomy, Roux-en-Y-gastrojejunostomy 4. Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit 5. Other biliary process which accounts for patient's abnormal liver function studies/imaging (i.e. significant non-anastomotic biliary stricture). |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University Medical Center | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | University of Barcelona, University of Rochester |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anastomotic biliary stricture resolution | Fluoroscopic (on ERCP image) resolution of stricture at the time of final study ERCP when all stents are removed | Immediately following final ERCP with stent removal | |
Secondary | Fluoroscopy Parameters | Fluoroscopy Time per fluoroscopy machine output | 1 day | |
Secondary | Adverse Events | Pancreatitis, bleeding, infection, perforation to be assessed one day and one week post-procedure | 1 week | |
Secondary | Sustained resolution of anastomotic stricture for 6 months | No evidence of recurrent stricture based on clinical status and laboratory studies | 6 months after final study ERCP with stent removal | |
Secondary | Sustained resolution of anastomotic stricture for 12 months | No evidence of recurrent stricture based on clinical status and laboratory studies | 12 months after final study ERCP with stent removal |
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