NCT00646685

Brief Summary

The purpose of this study is to empirically determine whether one of 2 surgical techniques commonly used for bile duct reconstruction during living donor liver transplantation results in fewer biliary complications. Also, this study may identify patient group(s) that particularly benefit from a particular technique.

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
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_4

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

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 25, 2014

Status Verified

June 1, 2012

Enrollment Period

7.4 years

First QC Date

March 25, 2008

Last Update Submit

July 24, 2014

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

  • Biliary complications defined as leaks and strictures within the first year post LDLT;

    1 year

Secondary Outcomes (4)

  • Graft and patient survival

    1 year post-transplant

  • Length of hospital-stay and ICU-stay

    within first 30 days after discharge

  • Any infection or rejection episodes

    1 year post- transplant

  • time to full oral nutrition

    within 30 days of discharge

Study Arms (2)

1

OTHER
Procedure: surgical technique: duct-to-duct biliary reconstruction

2

OTHER
Procedure: surgical technique: roux-en-y biliary reconstruction

Interventions

surgical technique: duct-to-duct biliary reconstructionPROCEDURE

surgical reconstruction

1
surgical technique: roux-en-y biliary reconstructionPROCEDURE

surgical reconstruction

2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient with end-stage liver disease
  • living donor liver transplantation using right hemi-liver as graft
  • duct anastomosis possible at time of surgery
  • donor and recipient aged 18 yrs or older
  • written informed consent obtained

You may not qualify if:

  • duct anastomosis not possible
  • acute fulminant liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

Study Officials

  • Markus Selzner, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 28, 2008

Study Start

February 1, 2008

Primary Completion

July 1, 2015

Study Completion

July 1, 2016

Last Updated

July 25, 2014

Record last verified: 2012-06

Locations

CA(1)