Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01907750
NCT01907750UnknownPhase 3

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

Mansoura University2 sites in 1 country180 target enrollmentStarted: January 2009Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 3
Enrollment
180
Locations
2
Primary Endpoint
early postoperative biliary fistula
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
2 Years to 70 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •multiple bile ducts

Outcomes

Primary Outcomes

early postoperative biliary fistula

Time Frame: 2 weeks

Secondary Outcomes

  • biliary stricture(2 years postoperatively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmad Mohammad Ahmad Sultan

Assistant professor

Mansoura University

Study Sites (2)

Loading locations...

Similar Trials

Not yet recruiting
Not Applicable
Modified Laparoscopic Transcystic Biliary Drainage in the Management of CholecystocholedocholithiasisCommon Bile Duct CalculiAcute Cholecystitis With ObstructionAcute CholangitisCholecystitis, Choledocholithiasis Acute
NCT06011941Peking University Third Hospital310
Completed
Not Applicable
Safety and efficacy of transpapillary biliary drainage using a long plastic stent for malignant distal biliary obstructioPatients with distal biliary obstruction due to unresectable malignant tumor
JPRN-UMIN000046530Kyoto Second Red Cross Hospital23
Unknown
Not Applicable
CBD Repair Over T-tube or Primary RepairCBD Exploration
NCT04108780Assiut University30
Completed
Not Applicable
Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary CancersPeriampullary Cancers With Obstructive JaundicePancreas Head CancerBile Duct CancerAmpulla of Vater Cancer
NCT01134276Seoul National University Hospital211
Completed
Not Applicable
Best Biliary Drainage Option in Advanced Klatskin TumorCholangitis
NCT03104582Hepatopancreatobiliary Surgery Institute of Gansu Province180