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

Официальное название

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.

Обзор

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.

Вмешательства

• Процедура Continous suture technique
  Duct-to-duct anastomosis will be performed using continuous suture technique for study group
• Процедура Interrupted suture technique
  Duct-to-duct anastomosis will be performed using an interrupted suture for control group,

Первичные конечные точки

• Bile leakage [Срок оценки: 90 days post transplantation]

Вторичные конечные точки (6)

• Critical biliary stricture [Срок оценки: 90 days post transplantation]
• Other surgical complications [Срок оценки: 90 days post transplantation]
• Long-term biliary complications [Срок оценки: 2 years post transplantation]
• Overall survival [Срок оценки: 2 years post transplantation]
• Overall graft survival [Срок оценки: 2 years post transplantation]
• Impact of the occurrence of a biliary complication on the quality of life of patients [Срок оценки: 2 years post transplantation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Польша · 1 центр

• Department of General, Transplantation and Liver Surgery UCC MUW — Warsaw

Идентификаторы

NCT: NCT06533592 · 2023/ABM/01/00017

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗