Study to Compare the Incidence of Biliary Complications After Liver Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Prospective Study to Compare the Incidence of Biliary Complications After Liver Transplantation

Conditions
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Liver Transplant; Complications

Intervention / Treatment
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* Device: Bard 5 Fr diameter feeding tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older will be undergoing liver transplantation able to give informed consent Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reconstruction with stent placement<br>Subjects will undergo biliary reconstruction with stent placement at the anastomosis site. | Device: Bard 5 Fr diameter feeding tube<br>* A pediatric feeding tube is used as a stent over which biliary anastomosis is performed. This is not a permanent stent and generally migrates out on its own.<br>|
| No Intervention: Reconstruction without stent placement<br>Subjects will undergo biliary reconstruction without stent placement. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Biliary Complications | 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. | 6 months after transplantation | 
| Number of Participants With Biliary Complications | 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. | 12 months after transplantation |