Transcystic Versus Transanastomotic Tube Drainage in Right Lobe LDLT

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Mansoura University
Sponsor:
Information provided by (Responsible Party):
Ahmad Mohammad Ahmad Sultan, Mansoura University
ClinicalTrials.gov Identifier:
NCT01907750
First received: June 23, 2013
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Living Donor Liver Transplantation
Device: biliary drainage tube
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Transcystic Versus Transanastomotic Biliary Drainage Tubes in Living Donor Liver Transplantation. A Prospective Randomized Trial.

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • early postoperative biliary fistula [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • biliary stricture [ Time Frame: 2 years postoperatively ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: January 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Transanastomotic tube
use of transanastomotic tube.
Device: biliary drainage tube
Active Comparator: Transcystic tube
use of transcystic tube to drain bile duct
Device: 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)
  Eligibility

Ages Eligible for Study:   2 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • multiple bile ducts
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01907750

Contacts
Contact: Ahmad M Sultan +201003886838 dr_ahmadsultan@hotmail.com
Contact: Tarek Salah Tarksal@yahoo.com

Locations
Egypt
Gastro-enterolgy surgical center, Mansoura University Recruiting
Mansoura, Al-Dakahleia, Egypt, 35516
Contact: ahmad M Sultan, MD    +201003886838    dr_ahmadsultan@hotmail.com   
Principal Investigator: Ahmad M Sultan, MD         
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Ahmad M Sultan, MD, PhD Gastro-enterology surgical center, Mansoura University
Study Chair: Mohammed Abdul-Wahab, MD, PhD Gastro-enterolgy surgical center, Mansoura University
Study Director: Tarek Salah, MD, PhD Gastro-enterolgy surgical center, Mansoura University
  More Information

No publications provided

Responsible Party: Ahmad Mohammad Ahmad Sultan, Assistant professor, Mansoura University
ClinicalTrials.gov Identifier: NCT01907750     History of Changes
Other Study ID Numbers: Biliary_TCvsTA
Study First Received: June 23, 2013
Last Updated: July 22, 2013
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
biliary fistula
biliary stricture
biliary drainage tube

ClinicalTrials.gov processed this record on September 22, 2014