Transcystic Versus Transanastomotic Tube Drainage in Right Lobe LDLT

Phase 3

• Conditions: Living Donor Liver Transplantation

• Registration Number: NCT01907750
• Lead Sponsor: Mansoura University

Brief Summary

To evaluate the safety and effectiveness of the use of transcystic biliary drainage tube (not transanastomotic) in comparison to the usual transanastomotic biliary drainage tube.

Detailed Description

a biliary drainage tube is usually inserted into the biliary passage after choledocho-choledochostomy (bile duct to bile duct joining).

A 4F or 5F biliary catheter (Marquat Genie biomedical, france) is used in all cases.

the study is to compare the effectiveness and safety of 2 different placement techniques:

1. the usual trans-anastomotic position (the tube is placed across the anastomosis line with the tip inside the intrahepatic biliary branches) through an opening in the wall of the recipient's common bile duct

2. a transcystic non-anastomotic position (the tube is placed through the cystic duct opening into the distal common bile duct not passing through anastomosis)

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2013-06-23
• Study First Submitted QC: 2013-07-22
• Study First Posted: 2013-07-25
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-28
• Primary Completion: 2016-03
• Last Update Posted: 2016-03-01
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• living donor liver transplantation
• single bile duct in the graft

Exclusion Criteria

• multiple bile ducts

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
early postoperative biliary fistula	2 weeks

Secondary Outcome Measures

Name	Time	Method
biliary stricture	2 years postoperatively

Trial Locations

Locations (1)

Gastro-enterolgy surgical center, Mansoura University; 🇪🇬 Mansoura, Al-Dakahleia, Egypt