The Effect of Remote Ischemic Preconditioning in Living Donor Hepatectomy

Asan Medical Center

Status: Completed

Conditions: Liver Transplantation; Tissue Donors; Ischemia Reperfusion Injury

Treatments: Procedure: remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03386435

RIPC_donor

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

RIPC

Experimental group

Description:

intervention: RIPC groups receive remote ischaemic preconditioning after anaesthesia induction and before surgery started.

Treatment:

Procedure: remote ischemic preconditioning

Control

No Intervention group

Description:

In the control group, the same maneuver was applied but without cuff inflation.