Study to Compare the Incidence of Biliary Complications After Liver Transplantation

Liver Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03165916
• Other study ID #: 140143
• Status: Completed
• Phase: N/A
• Start date: September 15, 2014
• Est. completion date: September 30, 2019

Study information

• Verified date: December 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older

• will be undergoing liver transplantation

• able to give informed consent

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Liver Transplant; Complications

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt Medical Center Liver Transplant Clinic	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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