Hepatocellular CancerNCT03594929
Effect of Remote Ischaemic preConditioning on Liver Injury in Patients Undergoing LIVER Resection Surgery
A study testing Active RIC in people with Hepatocellular Cancer, run by Singapore General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hepatocellular Cancer
- What is being tested?
- Active RIC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Aug 2016to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 21 years and above
- Patients undergoing partial hepatectomy for primary HC
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169608
Jin Yao Teo, 63214515, teo.jin.yao@singhealth.com.sg
About this study
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.
Read the 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.
- Conditions
- Hepatocellular Cancer
- Being tested
- Active RIC, Sham Control
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active RICDevice
Sham ControlDevice
| Study group | Role | What they receive |
|---|---|---|
| Active RIC | Active comparator | Active RIC using a manual BP cuff to inflate to 200mmHg. Receives: 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. Receives: Device: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum ALT (unit/L) following liver resection, measured at 24 hours
serum ALT as a measure of acute liver injury
Measured: 24 hours
serum AST (unit/L) following liver resection, measured at 24 hours
serum AST as a measure of acute liver injury
Measured: 24 hours
Secondary outcomes (14)
serum ALT (unit/L) following liver resection, measured at 6 hours
serum ALT as a measure of acute liver injury
Measured: 6 hours
serum ALT (unit/L) following liver resection, measured at 48 hours
serum ALT as a measure of acute liver injury
Measured: 48 hours
serum ALT (unit/L) following liver resection, measured at 2 weeks
serum ALT as a measure of acute liver injury
Measured: 2 weeks
serum AST (unit/L) following liver resection, measured at 6 hours
serum AST as a measure of acute liver injury
Measured: 6 hours
serum AST (unit/L) following liver resection, measured at 48 hours
serum AST as a measure of acute liver injury
Measured: 48 hours
serum ALT (unit/L) following liver resection, measured at 2 weeks
serum AST as a measure of acute liver injury
Measured: 2 weeks
Indocyanine Green (ICG) retention test.
Liver function as assessed by the ICG retention test. Testing is optional
Measured: 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
Measured: 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
Measured: Baseline and day 5 post-surgery
Episodes of culture-confirmed sepsis
Episodes of culture-confirmed sepsis
Measured: 30 days
Serum creatine (umol/L)
Measure of acute kidney injury based on rise in serum creatine on day 3 post op
Measured: 3 days
ITU and hospital stay
ITU and hospital stay
Measured: Up to 30 days
Rate of hospital admission
Rate of hospital admission
Measured: 30 days
Mortality
Mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start15 Aug 2016
- Primary completion18 Jan 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594929
- Sponsor's protocol ID
- The ERIC-LIVER trial
- Status last verified
- Jul 2018
- First submitted
- 19 Apr 2018
- Last updated
- 20 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischaemic preConditioning on Liver Injury in Patients Undergoing LIVER Resection Surgery: The ERIC-LIVER Trial
- ClinicalTrials.gov ID
- NCT03594929
- Acronym / sponsor ID
- The ERIC-LIVER trial
- Conditions
- Hepatocellular Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 18 Jan 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active RIC | Active comparator | Device: Active RICActive RIC using a manual BP cuff to inflate to 200mmHg. |
| Sham Control | Sham comparator | Device: Sham ControlA 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 21 years and above
- Patients undergoing partial hepatectomy for primary HC
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active RIC | Device | Active RIC |
| Sham Control | Device | Sham Control |
Primary outcome
serum ALT (unit/L) following liver resection, measured at 24 hours
Time frame: 24 hours
serum ALT as a measure of acute liver injury
serum AST (unit/L) following liver resection, measured at 24 hours
Time frame: 24 hours
serum AST as a measure of acute liver injury
14 secondary outcomes
serum ALT (unit/L) following liver resection, measured at 6 hours
Time frame: 6 hours
serum ALT (unit/L) following liver resection, measured at 48 hours
Time frame: 48 hours
serum ALT (unit/L) following liver resection, measured at 2 weeks
Time frame: 2 weeks
serum AST (unit/L) following liver resection, measured at 6 hours
Time frame: 6 hours
serum AST (unit/L) following liver resection, measured at 48 hours
Time frame: 48 hours
serum ALT (unit/L) following liver resection, measured at 2 weeks
Time frame: 2 weeks
Indocyanine Green (ICG) retention test.
Time frame: baseline in pre-admission clinic and post-operation day 1.
Acute liver ischemia reperfusion injury on histology
Time frame: up to 2 weeks
presence/absence of liver failure based on serum bilirubin and INR on post op day 5
Time frame: Baseline and day 5 post-surgery
Episodes of culture-confirmed sepsis
Time frame: 30 days
Serum creatine (umol/L)
Time frame: 3 days
ITU and hospital stay
Time frame: Up to 30 days
Rate of hospital admission
Time frame: 30 days
Mortality
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active RIC in people with Hepatocellular Cancer, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Yao Teo (63214515, teo.jin.yao@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum ALT (unit/L) following liver resection, measured at 24 hours (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.