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

Medical University of Warsaw

Status: Enrolling

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

Treatments: Procedure: Continous suture technique; Procedure: Interrupted suture technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06533592

2023/ABM/01/00017

Details and patient eligibility

About

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.

Enrollment: 284 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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284 participants in 2 patient groups

Continuous suture technique

Experimental group

Description:

Biliary duct-to-duct anastomosis performed with continous suture technique

Treatment:

Procedure: Continous suture technique

Interrupted suture

Active Comparator group

Description:

Biliary duct-to-duct anastomosis performed with interrupted suture technique - control group

Treatment:

Procedure: Interrupted suture technique