Transcystic Versus Transanastomotic Tube Drainage in Right Lobe LDLT

Living Donor Liver Transplantation Clinical Trial

Official title:

Transcystic Versus Transanastomotic Biliary Drainage Tubes in Living Donor Liver Transplantation. A Prospective Randomized Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01907750
• Other study ID #: Biliary_TCvsTA
• Status: Recruiting
• Phase: Phase 3
• First received: June 23, 2013
• Last updated: February 28, 2016
• Start date: January 2009
• Est. completion date: June 2016

Study information

• Verified date: February 2016
• Source: Mansoura University
• Contact: Ahmad M Sultan
• Phone: +201003886838
• Email: dr_ahmadsultan[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 70 Years

Eligibility

Inclusion Criteria:

• living donor liver transplantation

• single bile duct in the graft

Exclusion Criteria:

• multiple bile ducts

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Living Donor Liver Transplantation

Intervention

Device:
• biliary drainage tube

Locations

Country	Name	City	State
Egypt	Gastro-enterolgy surgical center, Mansoura University	Mansoura	Al-Dakahleia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early postoperative biliary fistula		2 weeks	Yes
Secondary	biliary stricture		2 years postoperatively	Yes