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
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplant; Complications||Device: Bard 5 Fr diameter feeding tube||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||138 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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
|United States, Tennessee|
|Vanderbilt Medical Center Liver Transplant Clinic|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Andrew Scanga, MD||Vanderbilt University Medical Center|