Study to Compare the Incidence of Biliary Complications After Liver Transplantation


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This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Andrew Scanga, Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT03165916

First received: May 18, 2017

Last updated: May 22, 2017

Last verified: May 2017

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.

Liver Transplant; Complications Device: Bard 5 Fr diameter feeding tube

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: A Randomized Controlled Prospective Study to Compare the Incidence of Biliary Complications After Liver Transplantation

Primary Outcome Measures:

  • Incidence of biliary complications [ Time Frame: 2 years after transplantation ]

    Biliary complications include biliary strictures, biliary leaks, cholangitis, and stones. The investigators will compare the number of complication between the group that receives the stent and the group that does not.

Estimated Enrollment: 120
Actual Study Start Date: September 15, 2014
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Experimental: Reconstruction with stent placement

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

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.

No Intervention: Reconstruction without stent placement

Subjects will undergo biliary reconstruction without stent placement.

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 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03165916

Vanderbilt Medical Center Liver Transplant Clinic
Nashville, Tennessee, United States, 37232

Vanderbilt University Medical Center

Principal Investigator: Andrew Scanga, MD Vanderbilt University Medical Center

Responsible Party: Andrew Scanga, Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03165916     History of Changes
Other Study ID Numbers: 140143
Study First Received: May 18, 2017
Last Updated: May 22, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

ClinicalTrials.gov processed this record on May 24, 2017