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

University Health Network, Toronto logo

University Health Network, Toronto

Status and phase

Unknown
Phase 4

Conditions

Liver Transplantation

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00646685
07-0498-B

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

1
Other group
Treatment:
Procedure: surgical technique: duct-to-duct biliary reconstruction
2
Other group
Treatment:
Procedure: surgical technique: roux-en-y biliary reconstruction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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