Transcystic Versus Transanastomotic Tube Drainage in Right Lobe LDLT

• Sponsor: Mansoura University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01907750
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 2
• Duration (Months): 89
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Living Donor Liver Transplantation	Device: biliary drainage tube	Phase 3

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)

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Transcystic Versus Transanastomotic Biliary Drainage Tubes in Living Donor Liver Transplantation. A Prospective Randomized Trial.
• Study Start Date: Jan 1, 2009
• Anticipated Primary Completion Date: Mar 1, 2016
• Anticipated Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. early postoperative biliary fistula [2 weeks]

Secondary Outcome Measures

1. biliary stricture [2 years postoperatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• living donor liver transplantation

• single bile duct in the graft

Exclusion Criteria:

• multiple bile ducts

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastro-enterolgy surgical center, Mansoura University	Mansoura	Al-Dakahleia	Egypt	35516

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmad Mohammad Ahmad Sultan, Assistant professor, Mansoura University
• ClinicalTrials.gov Identifier: NCT01907750
• Other Study ID Numbers: Biliary_TCvsTA
• First Posted: Jul 25, 2013
• Last Update Posted: Mar 1, 2016
• Last Verified: Feb 1, 2016

• Keywords provided by Ahmad Mohammad Ahmad Sultan, Assistant professor, Mansoura University: biliary fistula; biliary stricture; biliary drainage tube

Study Results

No Results Posted as of Mar 1, 2016