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Transcystic Versus Transanastomotic Tube Drainage in Right Lobe LDLT

Phase 3
Conditions
Living Donor Liver Transplantation
Interventions
Device: biliary drainage tube
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)

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
Arm && Interventions
GroupInterventionDescription
Transanastomotic tubebiliary drainage tubeuse of transanastomotic tube.
Transcystic tubebiliary drainage tubeuse of transcystic tube to drain bile duct
Primary Outcome Measures
NameTimeMethod
early postoperative biliary fistula2 weeks
Secondary Outcome Measures
NameTimeMethod
biliary stricture2 years postoperatively

Trial Locations

Locations (1)

Gastro-enterolgy surgical center, Mansoura University

🇪🇬

Mansoura, Al-Dakahleia, Egypt

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