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Completed

NCT Number: NCT03165916

Study to Compare the Incidence of Biliary Complications After Liver Transplantation

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.

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Key information

Conditions

Liver Transplant; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt Medical Center Liver Transplant Clinic

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Bard 5 Fr diameter feeding tube

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.

Primary outcomes

  1. Number of Participants With Biliary Complications

    Time frame: 6 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.

  2. Number of Participants With Biliary Complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
May 24, 2017
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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