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.
age over 18
elective liver transplantation
informed consent to participate in the study
recipient bile duct diameter over 3mm
age below 18
pregnancy
living donor liver transplantation
split-liver or reduced-size liver transplantation
Parallel
Continous suture technique
Procedure/SurgeryDuct-to-duct anastomosis will be performed using continuous suture technique for study group
Interrupted suture technique
Procedure/SurgeryDuct-to-duct anastomosis will be performed using an interrupted suture for control group,
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
Critical biliary stricture
Defined as the need for radiologic, endoscopic or operative intervention resulting from increased serum bilirubin concentration
Other surgical complications
Occurence of complication assessed in Clavien-Dindo scale
Long-term biliary complications
Defined as occurence of biliary leak, biliary stricture, peripheral cholangiopathy, recurrent cholangitis between 90 days and 2 years post transplantation
Overall survival
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