Effect of Remote Ischaemic preConditioning on Liver Injury in Patients Undergoing LIVER Resection Surgery

NCT03594929 | Unknown

• 1 other identifier: The ERIC-LIVER trial
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Cancer

Outcome Measures

Primary Outcomes (2)

• serum ALT (unit/L) following liver resection, measured at 24 hours

  serum ALT as a measure of acute liver injury

  24 hours

• serum AST (unit/L) following liver resection, measured at 24 hours

  serum AST as a measure of acute liver injury

  24 hours

Secondary Outcomes (14)

• serum ALT (unit/L) following liver resection, measured at 6 hours

  6 hours

• serum ALT (unit/L) following liver resection, measured at 48 hours

  48 hours

• serum ALT (unit/L) following liver resection, measured at 2 weeks

  2 weeks

• serum AST (unit/L) following liver resection, measured at 6 hours

  6 hours

• serum AST (unit/L) following liver resection, measured at 48 hours

  48 hours

Study Arms (2)

Active RIC

ACTIVE COMPARATOR

Active RIC using a manual BP cuff to inflate to 200mmHg.

Device: Active RIC

Sham Control

SHAM COMPARATOR

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

Interventions

Active RIC DEVICE

Active RIC

Sham Control DEVICE

Sham Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 21 years and above
• Patients undergoing partial hepatectomy for primary HC

You may not qualify if:

• Patients with significant pulmonary disease (FEV1\<40% predicted).
• Patients with known severe renal failure with a GFR\<30 mL/min/1.73 m2.
• Patients on sulphonylurea or nicorandil, as these medications may interfere with the protective effect of RIC.
• Patients recruited into another study which may impact on this study. Significant peripheral arterial disease affecting the upper limbs.
• Patients undergoing repeat liver resection surgery.

Sponsors & Collaborators

• Singapore General Hospital: lead
• Duke-NUS Graduate Medical School: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Central Study Contacts

Jin Yao Teo

CONTACT

63214515; teo.jin.yao@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: July 20, 2018
• Study Start: August 15, 2016
• Primary Completion: January 18, 2019
• Study Completion: April 1, 2019
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

SG (1)