Effect of Intermittent Hepatic Inflow Occlusion During Donor Hepatectomy In Adult Living Donor Liver Transplantation Using Right Hemiliver Grafts
18 Years
N/A
Both
End Stage Liver Disease, Living Donor
Trial Information
Effect of Intermittent Hepatic Inflow Occlusion During Donor Hepatectomy In Adult Living Donor Liver Transplantation Using Right Hemiliver Grafts
Intermittent hepatic inflow occlusion (IHIO) by clamping of the portal triad, also called
Pringle maneuver, is a safe and effective procedure in major hepatectomy in patients with
liver disease. IHIO minimizes blood loss and operation time during liver resection. In
addition, ischemic preconditioning with IHIO has been reported to have protective effects in
patients undergoing liver resection. In the setting of living donor liver transplantation
(LDLT), one of the most important concerns is liver donor safety. Several studies have shown
the safety of IHIO in donors for liver transplantation (LT). However, the effect of
preconditioning with IHIO during donor hepatectomy on LDLT recipients remains unclear.
Several small series have assessed the effects on recipients of ischemic preconditioning
during whole liver transplantation from deceased donors. The role of IHIO, however, has not
been fully elucidated in liver donors and recipients during LDLT. In this randomized,
prospective study, we'll evaluate the efficacy of IHIO in the recipients and donors.
Inclusion Criteria:
- Donors and recipient of LDLT, saged ≥18 years, who will undergo LDLT with donors
undergoing right hemihepatectomy and recipients receiving right hemiliver grafts
- Informed consent agreement
Exclusion Criteria:
- if the recipients has fulminant hepatic failure
- if the graft to recipient body weight ratio (GRWR) is <0.9
- if a frozen biopsy of the donor liver taken prior to donor hemihepatectomy shows >30%
macrovesicular steatosis
- if liver transplantation is ABO incompatible
- if recipients has received previous organ transplants
- if recipients has received or were scheduled to receive multi-organ transplants
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Serum alanine aminotransferase (ALT) concentration within 5 days post-operative
Outcome Description:
The primary end-point of this study is peak serum alanine aminotransferase (ALT) concentration within 5 days post-operation on donors and recipients.
Outcome Time Frame:
pre-operative and every day till 5 days post-operative
Safety Issue:
No
Principal Investigator
Jae-Won Joh, MD., PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Samsung Medical Center
Authority:
South Korea: Institutional Review Board
Study ID:
2007-09-096
NCT ID:
NCT01171742
Start Date:
July 2008
Completion Date:
August 2010
Related Keywords:
- End Stage Liver Disease
- Living Donor
- Liver Diseases
- End Stage Liver Disease
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