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

Prospective Randomized Trial for Comparison of Duct-to-duct and Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00646685
Enrollment
80
Registered
2008-03-28
Start date
2008-02-29
Completion date
2016-07-31
Last updated
2014-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation

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.

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.

Interventions

PROCEDUREsurgical technique: duct-to-duct biliary reconstruction

surgical reconstruction

PROCEDUREsurgical technique: roux-en-y biliary reconstruction

surgical reconstruction

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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

* duct anastomosis not possible * acute fulminant liver failure

Design outcomes

Primary

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

Secondary

MeasureTime frame
Graft and patient survival1 year post-transplant
Length of hospital-stay and ICU-staywithin first 30 days after discharge
Any infection or rejection episodes1 year post- transplant
time to full oral nutritionwithin 30 days of discharge

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026