CClinicalTrials.gg
Status unknownNCT00646685Updated Jul 25, 2014

Duct-to-duct vs Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation

A Phase 4 interventional study of surgical technique: duct-to-duct biliary reconstruction and surgical technique: roux-en-y biliary reconstruction in Liver Transplantation, sponsored by University Health Network, Toronto. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-07-25.

Sponsored by University Health Network, Toronto · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2012), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed description

The purpose of this study is to compare the incidence of biliary complications (bile leaks and strictures) following duct-to-duct and roux-en-y biliary reconstruction during right lobe living donor liver transplantation.

Biliary complications are much more common with right lobe living donor liver grafts than with whole organ grafts and are considered a major limitation of this surgery. Two surgical techniques are currently used for biliary reconstruction and each has its advantages/disadvantages. However, it is unclear which technique leads to fewer biliary complications. Retrospective studies which examine biliary complication rates may be hampered by such factors as a surgeon's bias or inexperience with a particular technique. Therefore a prospective randomized trial is needed.

02

Conditions studied

  • Liver Transplantation
03

In context

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • duct anastomosis not possible
  • acute fulminant liver failure
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Other
    1

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

  • Other
    2

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

Interventions

  • Proceduresurgical technique: duct-to-duct biliary reconstruction

    surgical reconstruction

  • Proceduresurgical technique: roux-en-y biliary reconstruction

    surgical reconstruction

06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. Graft and patient survival

    Time frame: 1 year post-transplant

  2. Length of hospital-stay and ICU-stay

    Time frame: within first 30 days after discharge

  3. Any infection or rejection episodes

    Time frame: 1 year post- transplant

  4. time to full oral nutrition

    Time frame: within 30 days of discharge

07

Study locations

1 site
  • Toronto General Hospital
    Toronto, Ontario M5G 2N2, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00646685
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Mar 28, 2008
Start date
Feb 2008
Primary completion
Jul 2015 (estimated)
Completion
Jul 2016 (estimated)
Last update
Jul 25, 2014

Study contacts

Markus Selzner, MD
principal investigator · University Health Network, Toronto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion