Clinical trial NCT03386435: The Effect of Remote Ischemic Preconditioning in Living Donor Hepatectomy
Official title: The Effect of Remote Ischemic Preconditioning on the Postoperative Liver Function in Living Donor Hepatectomy: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tissue Donors
Liver Transplantation
Ischemia Reperfusion Injury
Keywords: remote ischemic preconditioning
liver donors
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study group : remote ischemic preconditioning control group : none
Primary purpose: PREVENTION

Brief summary: Liver transplantation is the gold standard treatment for patients with end-stage liver disease. Despite its outstanding success, liver transplantation still entails certain complications including ischemia-reperfusion injury. Remote ischemic preconditioning is a novel and simple therapeutic method to lessen the harmful effects of ischemia-reperfusion injury, however, the majority of remote ischemic preconditioning studies on hepatic ischemia-reperfusion injury have been animal studies. Therefore, our aim was to assess the effects of remote ischemic preconditioning on postoperative liver function in living donor hepatectomy.

Detailed description: Liver transplantation(LT) is the gold standard treatment for patients with end-stage liver disease. In light of advancements in surgical techniques, immunosuppressive agents, and perioperative critical care, the overall 3-year survival of patients undergoing LT has exceeded 80%. Despite its outstanding success, LT still entails certain complications including ischemia-reperfusion injury (IRI).

IRI occurs when the blood supply to an organ or tissue is temporarily cut-off and then restored, and it is well-known as an underlying cause of primary non-function, biliary complications, and eventual graft loss after LT. Despite many attempts to ameliorate hepatic IRI, no definitive therapies have been established. In addition, the mechanisms of IRI remain largely unclear.

Remote ischemic preconditioning (RIPC) is a novel and simple therapeutic method to lessen the harmful effects of IRI. RIPC indicate that brief episodes of ischemia with intermittent reperfusion are introduced at a remote site, leading to systemic protection against subsequent insults as evinced on kidney, heart, liver, and other tissues. While RIPC has been shown to reduce hepatic IRI in several small animal studies, the beneficial effects of RIPC in hepatic IRI have been inconsistent. By far, the majority of RIPC studies on hepatic IRI have been animal studies; hence, there are limitations relating to the lack of human clinical trials.

Therefore, our aim was to assess the effects of RIPC on postoperative liver function in living donor hepatectomy.

Eligibility criteria: Inclusion Criteria:

* Donors who plan to have living right hepatectomy for liver transplantation.
* age : between 18 to 60 years.

Exclusion Criteria:

* donors who plan to donate left lobe
* donors who plan to have laparoscopic right hepatectomy
* donors who cannot proceed remote ischemic preconditioning

Primary outcomes:
measure: Postopera The Maximal Aspartate Aminotransferase Level Within 7 Postoperative Days
timeFrame: within 7 days after operation
measure: The Maximal Alanine Aminotransferase Level Within 7 Postoperative Days
timeFrame: within 7 days after operation
Secondary outcomes:
measure: Number of Participants With Delayed Recovery of Liver Function
timeFrame: postoperative 7 days
measure: Postoperative Liver Regeneration
timeFrame: 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
state: Songpa-gu
Study officials:
affiliation: Asan Medical Center
name: Jun-Gol Song, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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