Transcystic Versus Transanastomotic Tube Drainage in Righ... | NCT01907750

Studies
Transcystic Versus Transanastomotic Tube Drainage in Right Lobe LDLT

NCT01907750

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Mar 1, 2016Estimated

Enrollment

180Estimated

Phase

Phase 3

Conditions

Living Donor Liver Transplantation

Interventions

biliary drainage tube

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Mar 2016Estimated

Completion Date

Jun 2016Estimated

First Submitted Date

Jun 23, 2013

First Submission Date that Met QC Criteria

Jul 22, 2013

First Posted Date

Jul 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2016

Last Update Posted Date

Mar 1, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmad Mohammad Ahmad Sultan, Assistant professor, Mansoura UniversityPrincipal Investigator

Lead Sponsor

Mansoura UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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
a transcystic non-anastomotic position (the tube is placed through the cystic duct opening into the distal common bile duct not passing through anastomosis)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transanastomotic tube	Active Comparator	use of transanastomotic tube.	Device: biliary drainage tube
Transcystic tube	Active Comparator	use of transcystic tube to drain bile duct	Device: biliary drainage tube

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biliary drainage tube	Device		Transanastomotic tube Transcystic tube

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
early postoperative biliary fistula		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
biliary stricture		2 years postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

living donor liver transplantation
single bile duct in the graft

Exclusion Criteria:

multiple bile ducts

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmad M Sultan	Contact	+201003886838		dr_ahmadsultan@hotmail.com
Tarek Salah	Contact			Tarksal@yahoo.com

Overall Officials

Name	Affiliation	Role
Ahmad M Sultan, MD, PhD	Gastro-enterology surgical center, Mansoura University	Principal Investigator
Mohammed Abdul-Wahab, MD, PhD	Gastro-enterolgy surgical center, Mansoura University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gastro-enterolgy surgical center, Mansoura University	Recruiting	Al Mansurah	Al-Dakahleia	35516	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D001658	Biliary Fistula

Ancestor Terms

ID	Term
D016154	Digestive System Fistula
D004066	Digestive System Diseases
D005402	Fistula
D020763	Pathological Conditions, Anatomical

Browse Leaves

Not provided

Browse Branches

Not provided