Effect of Remote Ischaemic preConditioning on Liver Injury in Patients Undergoing LIVER Resection Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active RIC Active RIC using a manual BP cuff to inflate to 200mmHg. |
Device: Active RIC
|
| Sham Comparator: Sham Control 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
|
Outcome Measures
Primary Outcome Measures
- serum ALT (unit/L) following liver resection, measured at 24 hours [24 hours]
serum ALT as a measure of acute liver injury
- serum AST (unit/L) following liver resection, measured at 24 hours [24 hours]
serum AST as a measure of acute liver injury
Secondary Outcome Measures
- serum ALT (unit/L) following liver resection, measured at 6 hours [6 hours]
serum ALT as a measure of acute liver injury
- serum ALT (unit/L) following liver resection, measured at 48 hours [48 hours]
serum ALT as a measure of acute liver injury
- serum ALT (unit/L) following liver resection, measured at 2 weeks [2 weeks]
serum ALT as a measure of acute liver injury
- serum AST (unit/L) following liver resection, measured at 6 hours [6 hours]
serum AST as a measure of acute liver injury
- serum AST (unit/L) following liver resection, measured at 48 hours [48 hours]
serum AST as a measure of acute liver injury
- serum ALT (unit/L) following liver resection, measured at 2 weeks [2 weeks]
serum AST as a measure of acute liver injury
- Indocyanine Green (ICG) retention test. [baseline in pre-admission clinic and post-operation day 1.]
Liver function as assessed by the ICG retention test. Testing is optional
- Acute liver ischemia reperfusion injury on histology [up to 2 weeks]
Assessed by checking liver histology of the resected specimen
- presence/absence of liver failure based on serum bilirubin and INR on post op day 5 [Baseline and day 5 post-surgery]
serum bilirubin and INR on post op day 5
- Episodes of culture-confirmed sepsis [30 days]
Episodes of culture-confirmed sepsis
- Serum creatine (umol/L) [3 days]
Measure of acute kidney injury based on rise in serum creatine on day 3 post op
- ITU and hospital stay [Up to 30 days]
ITU and hospital stay
- Rate of hospital admission [30 days]
Rate of hospital admission
- Mortality [30 days]
Mortality
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients aged 21 years and above
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Patients undergoing partial hepatectomy for primary HC
Exclusion Criteria:
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Patients with significant pulmonary disease (FEV1<40% predicted).
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Patients with known severe renal failure with a GFR<30 mL/min/1.73 m2.
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Patients on sulphonylurea or nicorandil, as these medications may interfere with the protective effect of RIC.
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Patients recruited into another study which may impact on this study. Significant peripheral arterial disease affecting the upper limbs.
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Patients undergoing repeat liver resection surgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Singapore General Hospital | Singapore | Singapore | 169608 |
Sponsors and Collaborators
- Singapore General Hospital
- Duke-NUS Graduate Medical School
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- The ERIC-LIVER trial