Study to Compare the Incidence of Biliary Complications After Liver Transplantation

Vanderbilt University Medical Center

Status: Completed

Conditions: Liver Transplant; Complications

Treatments: Device: Bard 5 Fr diameter feeding tube

Study type: Interventional

Funder types: Other

Identifiers

NCT03165916

140143

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Reconstruction with stent placement

Experimental group

Description:

Subjects will undergo biliary reconstruction with stent placement at the anastomosis site.

Treatment:

Device: Bard 5 Fr diameter feeding tube

Reconstruction without stent placement

No Intervention group

Description:

Subjects will undergo biliary reconstruction without stent placement.