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

Biliary Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03229655
• Other study ID #: 41606
• Status: Recruiting
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Anastomotic Stenosis
• Biliary Stricture
• Cholestasis
• Constriction, Pathologic

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