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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 284
- 试验地点
- 2
- 主要终点
- Bile leakage
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Bile leakage
时间窗: 90 days post transplantation
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
次要结局
- Overall survival(2 years post transplantation)
- Overall graft survival(2 years post transplantation)
- Long-term biliary complications(2 years post transplantation)
- Other surgical complications(90 days post transplantation)
- Critical biliary stricture(90 days post transplantation)
- Impact of the occurrence of a biliary complication on the quality of life of patients(2 years post transplantation)