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

Primary Purpose

Anastomotic Stenosis, Biliary Stricture

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Protocol for increasing number of stents across the anastomosis

About this trial

This is an interventional treatment trial for Anastomotic Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Sites / Locations

Stanford University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sequential stent addition

Incremental Dilation & Stent Exchange

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Anastomotic biliary stricture resolution

Fluoroscopic (on ERCP image) resolution of stricture at the time of final study ERCP when all stents are removed

Secondary Outcome Measures

Fluoroscopy Parameters

Fluoroscopy Time per fluoroscopy machine output

Adverse Events

Pancreatitis, bleeding, infection, perforation to be assessed one day and one week post-procedure

Sustained resolution of anastomotic stricture for 6 months

No evidence of recurrent stricture based on clinical status and laboratory studies

Sustained resolution of anastomotic stricture for 12 months

No evidence of recurrent stricture based on clinical status and laboratory studies

Full Information

NCT ID

NCT03229655

First Posted

June 30, 2017

Last Updated

September 8, 2018

Sponsor

Stanford University

Collaborators

University of Rochester, University of Barcelona

1. Study Identification

Unique Protocol Identification Number

NCT03229655

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2017 (Actual)

Primary Completion Date

September 1, 2020 (Anticipated)

Study Completion Date

September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

University of Rochester, University of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anastomotic Stenosis, Biliary Stricture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized prospective study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sequential stent addition

Arm Type

Experimental

Arm Description

Arm Title

Incremental Dilation & Stent Exchange

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Protocol for increasing number of stents across the anastomosis

Intervention Description

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 Information:

Title

Anastomotic biliary stricture resolution

Description

Fluoroscopic (on ERCP image) resolution of stricture at the time of final study ERCP when all stents are removed

Time Frame

Immediately following final ERCP with stent removal

Secondary Outcome Measure Information:

Title

Fluoroscopy Parameters

Description

Fluoroscopy Time per fluoroscopy machine output

Time Frame

1 day

Title

Adverse Events

Description

Pancreatitis, bleeding, infection, perforation to be assessed one day and one week post-procedure

Time Frame

1 week

Title

Sustained resolution of anastomotic stricture for 6 months

Description

No evidence of recurrent stricture based on clinical status and laboratory studies

Time Frame

6 months after final study ERCP with stent removal

Title

Sustained resolution of anastomotic stricture for 12 months

Description

No evidence of recurrent stricture based on clinical status and laboratory studies

Time Frame

12 months after final study ERCP with stent removal

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Subhas Banerjee, MD

Phone

650-723-2623

sbanerje@stanford.edu

Facility Information:

Facility Name

Stanford University Medical Center

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Subhas Banerjee, MD

Phone

650-723-2623

sbanerje@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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