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

NCT03229655 | Unknown

• 1 other identifier: 41606
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Fluoroscopy Parameters

  1 day

• Adverse Events

  1 week

• Sustained resolution of anastomotic stricture for 6 months

  6 months after final study ERCP with stent removal

• Sustained resolution of anastomotic stricture for 12 months

  12 months after final study ERCP with stent removal

Study Arms (2)

Sequential stent addition

EXPERIMENTAL

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

Incremental Dilation & Stent Exchange

ACTIVE COMPARATOR

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

Interventions

Protocol for increasing number of stents across the anastomosis 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; Sequential stent addition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stanford University: lead
• University of Rochester: collaborator
• University of Barcelona: collaborator

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Interventions

Clinical Protocols

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Central Study Contacts

Subhas Banerjee, MD

CONTACT

650-723-2623; sbanerje@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Division of Gastroenterology

Model Details: Randomized prospective study

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 25, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2022
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)