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Study to Compare the Incidence of Biliary Complications After Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03165916
Recruitment Status : Active, not recruiting
First Posted : May 24, 2017
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew Scanga, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Liver Transplant; Complications Device: Bard 5 Fr diameter feeding tube Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Prospective Study to Compare the Incidence of Biliary Complications After Liver Transplantation
Actual Study Start Date : September 15, 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165916


Locations
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United States, Tennessee
Vanderbilt Medical Center Liver Transplant Clinic
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Andrew Scanga, MD Vanderbilt University Medical Center

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Responsible Party: Andrew Scanga, Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03165916     History of Changes
Other Study ID Numbers: 140143
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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