Clinical trial NCT06533592: The Effect of the Type of Conduit-duct Anastomosis Technique on the Postoperative Course in Patients Undergoing Liver Transplantation
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Transplant; Complications
Bile Duct; Stricture, Postoperative
Bile Leak
Quality of Life
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* age over 18
* elective liver transplantation
* informed consent to participate in the study
* recipient bile duct diameter over 3mm
* donor bile duct diameter over 3mm

Exclusion Criteria:

* age below 18
* pregnancy
* living donor liver transplantation
* split-liver or reduced-size liver transplantation
* liver transplantation other than from brain death donor
* liver transplantation with hepaticojejunostomy
* patients undergoing re-transplantation
* multi-organ transplantation
* recipient bile duct diameter below 3mm
* donor bile duct diameter below 3mm

Primary outcomes:
measure: Bile leakage
timeFrame: 90 days post transplantation
Secondary outcomes:
measure: Critical biliary stricture
timeFrame: 90 days post transplantation
measure: Other surgical complications
timeFrame: 90 days post transplantation
measure: Long-term biliary complications
timeFrame: 2 years post transplantation
measure: Overall survival
timeFrame: 2 years post transplantation
measure: Overall graft survival
timeFrame: 2 years post transplantation
measure: Impact of the occurrence of a biliary complication on the quality of life of patients
timeFrame: 2 years post transplantation
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of General, Transplantation and Liver Surgery UCC MUW
state: Masovian voivodeship
Study officials:
References: