Study to Compare the Incidence of Biliary Complications After Liver Transplantation

Not Applicable

Completed

• Conditions: Liver Transplant; Complications
• Interventions: Device: Bard 5 Fr diameter feeding tube

• Registration Number: NCT03165916
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

A randomized prospective study will be conducted of patients at Vanderbilt University Medical Center who undergo liver transplantation from March 2014 until approximately 120 patients are randomized. Patients will be randomized to undergo biliary reconstruction with and without stent placement.

Detailed Description

The risk of biliary complications can be related to the type of liver transplant performed and the technique used for reconstruction of the bile duct. One of the main techniques of performing biliary reconstruction is a choledocholedochostomy which can be performed over an anastomotic stent. Although placement of biliary stents is routine practice in many liver transplant centers around the country, there is no clear evidence to support their use. As of now both the placement and non-placement of a stent are essentially "standard of care". In the investigators' center, many of the transplant surgeons now perform the biliary anastomosis over a pediatric feeding tube which is used as a stent. The practice of using stents in biliary anastomosis is not uniform and there are no established guidelines to support their indiscriminate application. The investigators have designed a prospective randomized trial to evaluate the effect of stent placement on biliary complications and its effect on morbidity.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-09-15
• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-24
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Results First Submitted: 2020-06-03
• Results First Submitted QC: 2020-07-20
• Results First Posted: 2020-07-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• 18 years and older
• will be undergoing liver transplantation
• able to give informed consent

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reconstruction with stent placement	Bard 5 Fr diameter feeding tube	Subjects will undergo biliary reconstruction with stent placement at the anastomosis site.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Biliary Complications	12 months after transplantation	Biliary complications include biliary strictures, biliary leaks, cholangitis, and stones. The investigators will compare the number of complications between the group that receives the stent and the group that does not.

Trial Locations

Locations (1)

Vanderbilt Medical Center Liver Transplant Clinic; 🇺🇸 Nashville, Tennessee, United States