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
1 other identifier
interventional
146
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2014
CompletedFirst Submitted
Initial submission to the registry
May 18, 2017
CompletedFirst Posted
Study publicly available on registry
May 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedResults Posted
Study results publicly available
July 30, 2020
CompletedDecember 8, 2021
December 1, 2021
5 years
May 18, 2017
June 3, 2020
December 6, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
Reconstruction with stent placement
EXPERIMENTALSubjects will undergo biliary reconstruction with stent placement at the anastomosis site.
Reconstruction without stent placement
NO INTERVENTIONSubjects will undergo biliary reconstruction without stent placement.
Interventions
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.
Eligibility Criteria
You may qualify if:
- years and older
- will be undergoing liver transplantation
- able to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt Medical Center Liver Transplant Clinic
Nashville, Tennessee, 37232, United States
Results Point of Contact
- Title
- Tina Higginbotham
- Organization
- GI Clinical Research Enterprise
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Scanga, MD
Vanderbilt University Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 18, 2017
First Posted
May 24, 2017
Study Start
September 15, 2014
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
December 8, 2021
Results First Posted
July 30, 2020
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share