Recruiting

Sequential Stent Addition vs. Incremental Dilation

Sponsor:

Stanford University

Code:

NCT03229655

Conditions

Anastomotic Stenosis

Biliary Stricture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Protocol for increasing number of stents across the anastomosis

Study Details

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 ID

NCT03229655

Start date

Sep 1, 2017

Status verified date

Sep, 2018

Completion date

Sep 1, 2022

Anticipated

Primary completion date

Sep 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

Primary outcome measure

  • Anastomotic biliary stricture resolution [ Time Frame: Immediately following final ERCP with stent removal ]

Central Contacts and Locations

Central contacts

Subhas Banerjee, MD

650-723-2623sbanerje@stanford.edu

Locations

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94305

Contacts

Subhas Banerjee, MD

650-723-2623sbanerje@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Sep 11, 2018

Last verified

Sep, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2018-09-11.