Evaluation of Sequential Stent Addition vs. Incremental Dilation & Stent Exchange for Management of Anastomotic Biliary Strictures After Liver Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Sequential Stent Addition vs. Incremental Dilation & Stent Exchange for Management of Anastomotic Biliary Strictures After Liver Transplantation

Conditions
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Anastomotic Stenosis, Biliary Stricture

Intervention / Treatment
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* Procedure: Protocol for increasing number of stents across the anastomosis


Participation Criteria
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Eligibility Criteria
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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: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized prospective study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential stent addition<br>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. | Procedure: Protocol for increasing number of stents across the anastomosis<br>* Sequential placement of straight plastic biliary stents across the duct-to-duct anastomosis without dilation or stent exchange. Multiple ERCPs will be performed with addition of a single stent at each ERCP until the final ERCP when all stents will be removed.<br>|
| Active Comparator: Incremental Dilation & Stent Exchange<br>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. | Procedure: Protocol for increasing number of stents across the anastomosis<br>* Sequential placement of straight plastic biliary stents across the duct-to-duct anastomosis without dilation or stent exchange. Multiple ERCPs will be performed with addition of a single stent at each ERCP until the final ERCP when all stents will be removed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoroscopy Parameters | Fluoroscopy Time per fluoroscopy machine output | 1 day | 
| Adverse Events | Pancreatitis, bleeding, infection, perforation to be assessed one day and one week post-procedure | 1 week | 
| 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 | 
| 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 |