Bile Duct; Stricture, Postoperative, Bile Leak, Liver Transplant; Complications, Quality of Life
Conditions
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.
Interventions
PROCEDUREContinous suture technique
Duct-to-duct anastomosis will be performed using continuous suture technique for study group
PROCEDUREInterrupted suture technique
Duct-to-duct anastomosis will be performed using an interrupted suture for control group,
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bile leakage | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Critical biliary stricture | 90 days post transplantation | Defined as the need for radiologic, endoscopic or operative intervention resulting from increased serum bilirubin concentration |
| Long-term biliary complications | 2 years post transplantation | Defined as occurence of biliary leak, biliary stricture, peripheral cholangiopathy, recurrent cholangitis between 90 days and 2 years post transplantation |
| Other surgical complications | 90 days post transplantation | Occurence of complication assessed in Clavien-Dindo scale |
| Overall graft survival | 2 years post transplantation | — |
| Impact of the occurrence of a biliary complication on the quality of life of patients | 2 years post transplantation | Evaluated with EORTC QLQ-C30 form |
| Overall survival | 2 years post transplantation | — |
Countries
Poland
Contacts
Primary ContactKrzysztof Dudek, MD, PhD
Backup ContactJan Stypułkowski, MD
Outcome results
None listed