Pathophysiology and Prevention of Early Bile Duct Injury in Liver Transplantation: The role of the additional In-Situ Bile Duct Flush

Not Applicable

Completed

• Conditions: Bile Duct Injury in Liver Transplantation; Biliary complications after liver transplantation; Surgery - Surgical techniques; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12616000278437
• Lead Sponsor: Royal Prince Alfred Transplant Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-02
• Study Completion: 2020-12-31
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

All liver donors retrieved with the intent to be transplanted at the ANLTU will be included in the study

Exclusion Criteria

Organ donors who are not eligible for Liver donation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical development of biliary complications (bile leaks, biliary strictures) . Biliary complications identified from medical records,<br>Operation reports, imaging reports of recipients.[24 months post transplant<br>];Histological Injury in Donor Bile Duct Specimens<br>[At end of cold storage during the backtable procedure.<br>]

Secondary Outcome Measures

Name	Time	Method
To determine whether there is a difference in severity of pretransplant bile duct injury, including peribiliary glands and vascular plexus between the intervention group and control livers[Histological samples are taken at the backtable procedure at the recipient transplant surgery and 10minutes after reperfusion of the liver, before bile duct anastomosis];To clarify the potential role of biliary stem cells in biliary complications after LT [Histological samples are taken at the backtable procedure at the recipient transplant surgery and 10minutes after reperfusion of the liver, before bile duct anastomosis];To determine impact of injury of peribiliary glands in development of post-transplant biliary strictures [12 months post-transplant]