Carbon Monoxide Measurement for Liver Regeneration

Overseen By Raquel Molina

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Englewood Hospital and Medical Center

Disqualifiers: Under 18, Vulnerable populations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

125 Participants Needed

Trial Summary

What is the purpose of this trial?

the investigators will pursue two specific aims: (1) to monitor the extent of heme oxygenase induction (by measuring endogenous CO production) in relationship to the extent of hepatic resection (2) to assess the production of CO in patients following liver resection and correlate these findings to the rate of liver regeneration and liver function.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Carbon Monoxide Measurement for liver regeneration?

Research shows that carbon monoxide levels decrease significantly in patients after liver transplantation, indicating a potential role in monitoring liver function and regeneration. Additionally, carbon monoxide has been found to have protective effects against liver injury in animal studies, suggesting it might help in liver recovery. ^{1 2 3 4 5}

Is carbon monoxide measurement for liver regeneration safe for humans?

There is no specific safety data available for carbon monoxide measurement in liver regeneration, but general liver safety is a key focus in drug development, and liver toxicity is often monitored through sensitive tests. Liver toxicity can be reversible and is usually detected in later stages of drug development. ^{6 7 8 9 10}

How does carbon monoxide measurement differ from other treatments for liver regeneration?

This treatment is unique because it uses the measurement of exhaled carbon monoxide (CO) as a potential marker for liver regeneration, which is not a standard approach. It focuses on monitoring CO levels to assess liver injury and recovery, unlike traditional treatments that may not use such biomarkers. ^{1 2 4 11 12}

Research Team

Cherif Boutros, MD

Principal Investigator

Englewood Hospital

Eligibility Criteria

This trial is for individuals undergoing partial hepatectomy, a surgical procedure to remove part of the liver. It's aimed at those who may have conditions like liver cancer or hepatocellular carcinoma and are interested in monitoring their liver regeneration post-surgery.

Inclusion Criteria

I am planning to undergo surgery to remove part of my liver due to cancer.

I understand and am willing to sign the consent form.

Exclusion Criteria

Patients identified as members of a vulnerable population, except women of childbearing potential with negative pregnancy test

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Assessment

Participants provide baseline breath samples to measure carbon monoxide levels

1 day

1 visit (in-person)

Post-surgery Monitoring

Participants provide breath samples at 4 and 24 hours post-resection to measure carbon monoxide levels

1 day

2 visits (in-person)

Follow-up

Participants undergo CT liver volumetric studies and blood tests to assess liver regeneration and function

3 months

2 visits (in-person)

Treatment Details

Interventions

• Carbon Monoxide Measurement

Trial Overview The study is testing a method to measure carbon monoxide (CO) production using a device called smokerlyzer. The goal is to see if CO levels can indicate how well the liver regenerates after surgery and predict recovery outcomes.

Participant Groups

Group I: all participants Experimental Treatment 1 Intervention

all participants will provide breath samples to detect carbon monoxide levels

Who Is Running the Clinical Trial?

Englewood Hospital and Medical Center

Lead Sponsor

Trials

21

Recruited

770+

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of Liver Transplantation on Carbon Monoxide Production as Measured by Arterial Carboxyhemoglobin Levels in Cirrhotic Patients with and without Hepatopulmonary Syndrome. [2021]

2. Greece pubmed.ncbi.nlm.nih.gov

Increased exhaled carbon monoxide concentration during living donor liver transplantation. [2022]

3. Greece pubmed.ncbi.nlm.nih.gov

Carbon monoxide hemoglobin and bilirubin metabolism in adult living-related liver transplantation. [2013]

4. Greece pubmed.ncbi.nlm.nih.gov

Heme breakdown and ischemia/reperfusion injury in grafted liver during living donor liver transplantation. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

The Protective Effects of Carbon Monoxide Against Hepatic Warm Ischemia-Reperfusion Injury in MHC-Inbred Miniature Swine. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Monitoring liver safety in drug development: the GSK experience. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Oral medications with significant hepatic metabolism at higher risk for hepatic adverse events. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Drug, Herb, and Dietary Supplement Hepatotoxicity. [2018]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Anti-tuberculosis drug-induced liver injury in Shanghai: validation of Hy's Law. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Hepatotoxicity in drug development: detection, significance and solutions. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Continuous Endogenous Exhaled CO Monitoring by Laser Spectrometer in Human EVLP Before Lung Transplantation. [2022]

12. Japan pubmed.ncbi.nlm.nih.gov

Hemodynamic Implications of Carbon Monoxide (CO) and Nitrogen Oxide (NO) during Living Donor Liver Transplantation. [2018]