NCT03165916

Study to Compare the Incidence of Biliary Complications After Liver Transplantation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Transplant; Complications

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2014-09-15
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2017-05-24
• Last updated: 2021-12-08
• Results posted: 2020-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study