The Effect of the Type of Conduit-duct Anastomosis Technique on the Postoperative Course in Patients Undergoing Liver Transplantation
NCT Number: NCT06533592
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Liver Transplant; Complications|Bile Duct; Stricture, Postoperative|Bile Leak|Quality of Life
Interventions: PROCEDURE: Continous suture technique|PROCEDURE: Interrupted suture technique
Sponsor: Medical University of Warsaw
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 284
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2028-09-01

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.

Primary Outcome Measures: Bile leakage, Defined as bilirubin concentration in the drain fluid at least 3 times the serum bilirubin concentration or as the need for radiologic or operative intervention resulting from biliary collections or bile peritonitis up to 90 days post transplantation, 90 days post transplantation
Secondary Outcome Measures: Critical biliary stricture, Defined as the need for radiologic, endoscopic or operative intervention resulting from increased serum bilirubin concentration, 90 days post transplantation|Other surgical complications, Occurence of complication assessed in Clavien-Dindo scale, 90 days post transplantation|Long-term biliary complications, Defined as occurence of biliary leak, biliary stricture, peripheral cholangiopathy, recurrent cholangitis between 90 days and 2 years post transplantation, 2 years post transplantation|Overall survival, 2 years post transplantation|Overall graft survival, 2 years post transplantation|Impact of the occurrence of a biliary complication on the quality of life of patients, Evaluated with EORTC QLQ-C30 form, 2 years post transplantation