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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03229655
Other study ID # 41606
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date September 1, 2022

Study information

Verified date September 2018
Source Stanford University
Contact Subhas Banerjee, MD
Phone 650-723-2623
Email sbanerje@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 1, 2022
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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.

Locations

Country Name City State
United States Stanford University Medical Center Stanford California

Sponsors (3)

Lead Sponsor Collaborator
Stanford University University of Barcelona, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Fluoroscopy Parameters Fluoroscopy Time per fluoroscopy machine output 1 day
Secondary Adverse Events Pancreatitis, bleeding, infection, perforation to be assessed one day and one week post-procedure 1 week
Secondary 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
Secondary 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
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