Hepatocellular Cancer Clinical Trial
Official title:
Effect of Remote Ischaemic preConditioning on Liver Injury in Patients Undergoing LIVER Resection Surgery: The ERIC-LIVER Trial
Liver resection has improved health outcomes in patients with hepatocellular carcinoma (HCC) in Singapore and worldwide. However, due to acute ischaemia/reperfusion injury (IRI) to the liver at the time of surgery, patients still experience significant morbidity and mortality. Therefore, novel therapies are required to protect the liver against acute IRI during partial hepatectomy. Remote ischaemic conditioning (RIC) using transient limb ischaemia/reperfusion has been shown to protect the liver in experimental animal studies. In the ERIC-LIVER trial the investigators investigate whether RIC can reduce liver injury and preserve liver function in patients with HCC undergoing partial hepatectomy.
Liver resection has improved health outcomes in patients with hepatocellular carcinoma (HCC)
in Singapore and worldwide. However, due to acute ischaemia/reperfusion injury (IRI) to the
liver at the time of surgery, patients still experience significant morbidity and mortality.
Therefore, novel therapies are required to protect the liver against acute IRI during partial
hepatectomy. Remote ischaemic conditioning (RIC) using transient limb ischaemia/reperfusion
has been shown to protect the liver in experimental animal studies. In the ERIC-LIVER trial
the investigators investigate whether RIC can reduce liver injury and preserve liver function
in patients with HCC undergoing partial hepatectomy.
50 patients with HCC undergoing partial hepatectomy will be randomised to receive either RIC
(four-5 minute arm cuff inflations/deflations) or sham control (four-5 minute arm cuff
simulated inflations/deflations) after induction of anesthesia and prior to surgical
incision. The primary endpoint of the study will be acute liver injury assessed by serum
transaminases measured at 24 hours post-resection. Secondary endpoints will include liver
function in subset of patients (N=24, assessed by indocyanine green [ICG] clearance measured
at 24 hours post-resection), incid ence of liver failure, episodes of confirmed sepsis, acute
kidney injury, intensive care unit and hospital stay, and quality of life.
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