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.

Study Overview

• Status: Unknown
• Conditions: Biliary Stricture; Anastomotic Stenosis
• Intervention / Treatment: Procedure: Protocol for increasing number of stents across the anastomosis

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University Medical Center
      • Contact: Subhas Banerjee, MD; Phone Number: 650-723-2623; Email: sbanerje@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: 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.
ACTIVE_COMPARATOR: 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.	Procedure: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: University of Rochester; University of Barcelona

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (ACTUAL): July 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 8, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Biliary Tract Diseases; Bile Duct Diseases; Constriction, Pathologic; Cholestasis
• Other Study ID Numbers: 41606

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No