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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01907750
Other study ID # Biliary_TCvsTA
Secondary ID
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
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