Effect of Intermittent Hepatic Inflow Occlusion During Donor Hepatectomy In Living Donor Liver Transplantation
This trial is active, not recruiting.
|Conditions||end stage liver disease, living donor|
|Treatment||intermittent hepatic inflow occlusion (ihio)|
|Sponsor||Samsung Medical Center|
|Start date||July 2008|
|End date||June 2010|
|Trial size||50 participants|
|Trial identifier||NCT01171742, 2007-09-096|
Intermittent hepatic inflow occlusion (IHIO), also called Pringle maneuver, is a safe and effective procedure for major hepatectomy in patients with liver disease. In addition, ischemic preconditioning with IHIO has been reported to have protective effects in patients undergoing liver resection. The role of IHIO, however, has not been fully elucidated in donors and recipients during living donor liver transplantation.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Serum alanine aminotransferase (ALT) concentration within 5 days post-operative
time frame: pre-operative and every day till 5 days post-operative
post-operative clinical courses, such as liver function tests, hospital stay, and morbidity
time frame: During post-operative 1 months or hospitalization
Serum interleukin (IL)-6, IL-8, tumor necrosis factor (TNF)- α, and hepatocyte growth factor (HGF)
time frame: In donors immediately after anesthesia induction and 2 hours after graft removal, and in recipients immediately after anesthesia induction, during the anhepatic phase, 2 hours after reperfusion, and at 1 and 3 days post-operatively.
Caspase-3 and malondialdehyde in liver biopsy
time frame: In donors at the time of laparotomy, just before portal vein and hepatic artery clamping after parenchymal resection, and in recipients two hours after reperfusion
Male or female participants at least 18 years old.
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
|Official title||Effect of Intermittent Hepatic Inflow Occlusion During Donor Hepatectomy In Adult Living Donor Liver Transplantation Using Right Hemiliver Grafts|
|Principal investigator||Jae-Won Joh, MD., PhD|
|Description||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.|
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