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Study to Compare the Incidence of Biliary Complications After Liver Transplantation

NCT ID: NCT03165916

Last Updated: 2021-12-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-15

Study Completion Date

2019-09-30

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.

Conditions

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Liver Transplant; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Reconstruction with stent placement

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

Group Type EXPERIMENTAL

Bard 5 Fr diameter feeding tube

Intervention Type DEVICE

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.

Reconstruction without stent placement

Subjects will undergo biliary reconstruction without stent placement.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bard 5 Fr diameter feeding tube

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Andrew Scanga

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Scanga, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt Medical Center Liver Transplant Clinic

Nashville, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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140143

Identifier Type: -

Identifier Source: org_study_id