This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Andrew Scanga, Vanderbilt University Medical Center
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 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|
- 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.
|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|
- 18 years and older
- will be undergoing liver transplantation
- able to give informed consent
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