Transcystic Versus Transanastomotic Tube Drainage in Right Lobe LDLT

Mansoura University

Status and phase: Unknown; Phase 3

Conditions: Living Donor Liver Transplantation

Treatments: Device: biliary drainage tube

Study type: Interventional

Funder types: Other

Identifiers

NCT01907750

Biliary_TCvsTA

Details and patient eligibility

About

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.

Full 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)

Enrollment: 180 estimated patients

Sex: All

Ages: 2 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• multiple bile ducts

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Transanastomotic tube

Active Comparator group

Description:

use of transanastomotic tube.

Treatment:

Device: biliary drainage tube

Transcystic tube

Active Comparator group

Description:

use of transcystic tube to drain bile duct

Treatment:

Device: biliary drainage tube