NCT06533592

The Effect of the Type of Conduit-duct Anastomosis Technique on the Postoperative Course in Patients Undergoing Liver Transplantation

A Prospective Randomized Study to Evaluate the Effect of the Type of Conduit-duct Anastomosis Using the Single/continuous Suture Technique on the Postoperative Course in Patients Undergoing Liver Transplantation from a Deceased Donor.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 284 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the trial is to compare the effect of two end-to-end duct-to-duct anastomosis surgical techniques using the continuous suture method versus interrupted method (control group) on reducing the risk of bile leakages in the 90-day follow-up period after liver transplantation and other postoperative complications resulting from them i.e.: the occurrence of a critical stenosis in the duct-to-duct anastomosis within 90 days. In addition, as part of the research experiment, long-term biliary complications will be assessed, i.e. occurring over a period of more than 90 days (a 2-year observation period of patients was assumed). As part of the trial 284 patients qualified for the procedure of liver transplantation from a deceased donor will be included, in whom end-to-end anastomosis of the bile ducts will be performed. After entering the study, patients will be randomized to one of the groups. In the group of 142 patients, duct-to-duct anastomosis will be performed using an interrupted suture (control group), and the remaining patients will be performed using the continuous suture technique. The analysis will also include surgical complications, complications related to early and late graft function, retransplantation and overall survival. Additionally the analyses an analysis of the impact of the occurrence of a biliary complication on the quality of life of patients after liver transplantation will be performed on the basis of the EORTC QLQ-C30 forms. The period of observation of the patient after the procedure is planned for 24 months.

Conditions

• Liver Transplant; Complications
• Bile Duct; Stricture, Postoperative
• Bile Leak
• Quality of Life

Interventions

Type	Name	Description
PROCEDURE	Continous suture technique	Duct-to-duct anastomosis will be performed using continuous suture technique for study group
PROCEDURE	Interrupted suture technique	Duct-to-duct anastomosis will be performed using an interrupted suture for control group,

Timeline

• Start date: 2024-09-28
• Primary completion: 2026-11-01
• Completion: 2028-09-01
• First posted: 2024-08-01
• Last updated: 2024-10-24

Locations

1 site across 1 country: Poland