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

NCT ID: NCT03229655

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2022-09-01

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.

Conditions

Anastomotic Stenosis; Biliary Stricture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Protocol for increasing number of stents across the anastomosis

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Protocol for increasing number of stents across the anastomosis

Intervention Type: PROCEDURE

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.

Interventions

Protocol for increasing number of stents across the anastomosis

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: collaborator

University of Barcelona

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Subhas Banerjee

Associate Professor of Medicine, Division of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University Medical Center

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Subhas Banerjee, MD

Role: CONTACT

sbanerje@stanford.edu

650-723-2623

Facility Contacts

Subhas Banerjee, MD

Role: primary

sbanerje@stanford.edu

650-723-2623

Other Identifiers

41606

Identifier Type: -

Identifier Source: org_study_id