NCT01907750

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

7.2 years

First QC Date

June 23, 2013

Last Update Submit

February 28, 2016

Conditions

Living Donor Liver Transplantation

Keywords

biliary fistulabiliary stricturebiliary drainage tube

Outcome Measures

Primary Outcomes (1)

  • early postoperative biliary fistula

    2 weeks

Secondary Outcomes (1)

  • biliary stricture

    2 years postoperatively

Study Arms (2)

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

biliary drainage tubeDEVICE
Transanastomotic tubeTranscystic tube

Eligibility Criteria

Age2 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • multiple bile ducts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastro-enterolgy surgical center, Mansoura University

Al Mansurah, Al-Dakahleia, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Biliary Fistula

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • 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

  • Tarek Salah, MD, PhD

    Gastro-enterolgy surgical center, Mansoura University

    STUDY DIRECTOR

Central Study Contacts

Ahmad M Sultan

CONTACT

+201003886838dr_ahmadsultan@hotmail.com

Tarek Salah

CONTACT

Tarksal@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 23, 2013

First Posted

July 25, 2013

Study Start

January 1, 2009

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

March 1, 2016

Record last verified: 2016-02

Locations

EG(1)