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

Not Applicable

• Conditions: Anastomotic Stenosis; Biliary Stricture
• Interventions: Procedure: Protocol for increasing number of stents across the anastomosis

• Registration Number: NCT03229655
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-07-24
• Study First Posted: 2017-07-25
• Study Start: 2017-09-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-08
• Last Update Posted: 2018-09-11
• Primary Completion: 2020-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequential stent addition	Protocol for increasing number of stents across the anastomosis	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.
Incremental Dilation & Stent Exchange	Protocol for increasing number of stents across the anastomosis	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.

Primary Outcome Measures

Name	Time	Method
Anastomotic biliary stricture resolution	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 Outcome Measures

Name	Time	Method
Fluoroscopy Parameters	1 day	Fluoroscopy Time per fluoroscopy machine output
Adverse Events	1 week	Pancreatitis, bleeding, infection, perforation to be assessed one day and one week post-procedure
Sustained resolution of anastomotic stricture for 6 months	6 months after final study ERCP with stent removal	No evidence of recurrent stricture based on clinical status and laboratory studies
Sustained resolution of anastomotic stricture for 12 months	12 months after final study ERCP with stent removal	No evidence of recurrent stricture based on clinical status and laboratory studies

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States