An interventional study of Active RIC and Sham Control in Hepatocellular Cancer, sponsored by Singapore General Hospital. Status unknown at 1 site in Singapore. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2018-07-20.
Sponsored by Singapore General Hospital · Not applicable, Interventional, and Treatment
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.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's planned enrollment of 50 is close to the median of 47 across 968 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Singapore General Hospital is the lead sponsor of 266 studies on the registry; 57 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Active RIC using a manual BP cuff to inflate to 200mmHg.
Device: Active RIC
A sham control using a manual blood pressure cuff visually identical to that used in the RIC protocol will be placed on the upper arm and a simulated RIC protocol will be administered.
Device: Sham Control
serum ALT (unit/L) following liver resection, measured at 24 hours
serum ALT as a measure of acute liver injury
Time frame: 24 hours
serum AST (unit/L) following liver resection, measured at 24 hours
serum AST as a measure of acute liver injury
Time frame: 24 hours
serum ALT (unit/L) following liver resection, measured at 6 hours
serum ALT as a measure of acute liver injury
Time frame: 6 hours
serum ALT (unit/L) following liver resection, measured at 48 hours
serum ALT as a measure of acute liver injury
Time frame: 48 hours
serum ALT (unit/L) following liver resection, measured at 2 weeks
serum ALT as a measure of acute liver injury
Time frame: 2 weeks
serum AST (unit/L) following liver resection, measured at 6 hours
serum AST as a measure of acute liver injury
Time frame: 6 hours
serum AST (unit/L) following liver resection, measured at 48 hours
serum AST as a measure of acute liver injury
Time frame: 48 hours
serum ALT (unit/L) following liver resection, measured at 2 weeks
serum AST as a measure of acute liver injury
Time frame: 2 weeks
Indocyanine Green (ICG) retention test.
Liver function as assessed by the ICG retention test. Testing is optional
Time frame: baseline in pre-admission clinic and post-operation day 1.
Acute liver ischemia reperfusion injury on histology
Assessed by checking liver histology of the resected specimen
Time frame: up to 2 weeks
presence/absence of liver failure based on serum bilirubin and INR on post op day 5
serum bilirubin and INR on post op day 5
Time frame: Baseline and day 5 post-surgery
Episodes of culture-confirmed sepsis
Episodes of culture-confirmed sepsis
Time frame: 30 days
Serum creatine (umol/L)
Measure of acute kidney injury based on rise in serum creatine on day 3 post op
Time frame: 3 days
ITU and hospital stay
ITU and hospital stay
Time frame: Up to 30 days
Rate of hospital admission
Rate of hospital admission
Time frame: 30 days
Mortality
Mortality
Time frame: 30 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Singapore General Hospital