Liver Cancer AdultNCT06681818
Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy
A study testing carbon monoxide measurement via smokerlyzer in people with Liver Cancer Adult and Liver Regeneration, run by Englewood Hospital and Medical Center at 1 site in United States.
Trial summary
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 or ablation(2) to assess the production of CO in patients following liver resection or ablation and correlate these findings… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer Adult, Liver Regeneration
- What is being tested?
- carbon monoxide measurement via smokerlyzer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2024to 1 Jan 2039
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient plans to have an ablation or partial liver resection for primary liver pathology or metastatic disease
- Patient is able to comprehend and willing to sign the written consent form
Who cannot join
- Patients < 18 years
- Patients identified as members of a vulnerable population, except women of child bearing potential with negative pregnancy test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Raquel Molina contact
United States1 site, 1 recruiting
- Recruiting
Englewood Hospital
Englewood, New Jersey, 07631
Jamie Ketas, 2018943418, jamie.ketas@ehmchealth.org
Raquel Molina, raquel.molina@ehmchealth.org
About this study
Official title: Postoperative Heme Oxygenase Induction and Carbon Monoxide Production as a Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy
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 or ablation(2) to assess the production of CO in patients following liver resection or ablation and correlate these findings to the rate of liver regeneration and liver function.
- Conditions
- Liver Cancer Adult, Liver Regeneration
- Being tested
- carbon monoxide measurement via smokerlyzer
- Keywords
- hepatectomy, ablation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon monoxide measurement via smokerlyzerOther
participants in this study will provide breath samples for carbon monoxide measurements pre and post liver resection
| Study group | Role | What they receive |
|---|---|---|
| all participants | Experimental | all participants will provide breath samples to detect carbon monoxide levels Receives: Other: carbon monoxide measurement via smokerlyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of carbon monoxide levels in exhaled breath with quantity and quality of liver regeneration
patients will be asked to donate exhaled breath into a smokerlyzer device
Measured: measurements will be taken pre, then 4 hours and 24 hours post resection
Secondary outcomes (3)
level of carbon monoxide in exhaled air of patients
patients will be asked to donate exhaled breath into a smokerlyzer device
Measured: measurements will be taken pre, then 4 hours and 24 hours post resection
quantity of liver regeneration, liver volume (ml)
CT liver volumetric studies
Measured: one and three months after resection
quality of hepatic regeneration, normalized liver function
serum protein, albumin, AST and ALT, alkaline phosphatase, and bilirubin level
Measured: one and three months post resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start21 Nov 2024
- Primary completion1 Jan 2039 (estimated)
- Study completion1 Jan 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cancer AdultStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Englewood Hospital and Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cherif Boutros, MD, Principal investigator, Englewood Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681818
- Sponsor's protocol ID
- E-24-982
- Status last verified
- Oct 2026
- First submitted
- 6 Nov 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Heme Oxygenase Induction and Carbon Monoxide Production as a Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy
- ClinicalTrials.gov ID
- NCT06681818
- Acronym / sponsor ID
- E-24-982
- Conditions
- Liver Cancer Adult, Liver Regeneration
- Keywords
- hepatectomy, ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Englewood Hospital and Medical CenterUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 1 Jan 2039 (estimated)
- Study completion
- 1 Jan 2039 (estimated)
- First posted
- 8 Nov 2024 (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.
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 or ablation(2) to assess the production of CO in patients following liver resection or ablation and correlate these findings to the rate of liver regeneration and liver function.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all participants | Experimental | Other: carbon monoxide measurement via smokerlyzerall participants will provide breath samples to detect carbon monoxide levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient plans to have an ablation or partial liver resection for primary liver pathology or metastatic disease
- Patient is able to comprehend and willing to sign the written consent form
Key exclusion criteria (2 listed)
- Patients < 18 years
- Patients identified as members of a vulnerable population, except women of child bearing potential with negative pregnancy test
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 |
|---|---|---|
| carbon monoxide measurement via smokerlyzerparticipants in this study will provide breath samples for carbon monoxide measurements pre and post liver resection | Other | all participants |
Primary outcome
correlation of carbon monoxide levels in exhaled breath with quantity and quality of liver regeneration
Time frame: measurements will be taken pre, then 4 hours and 24 hours post resection
patients will be asked to donate exhaled breath into a smokerlyzer device
3 secondary outcomes
level of carbon monoxide in exhaled air of patients
Time frame: measurements will be taken pre, then 4 hours and 24 hours post resection
quantity of liver regeneration, liver volume (ml)
Time frame: one and three months after resection
quality of hepatic regeneration, normalized liver function
Time frame: one and three months post resection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Raquel Molina contact
Cherif Boutros, MD principal investigator
Englewood Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carbon monoxide measurement via smokerlyzer in people with Liver Cancer Adult and Liver Regeneration, run by Englewood Hospital and Medical Center at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. 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 United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie Ketas (2018943418, jamie.ketas@ehmchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation of carbon monoxide levels in exhaled breath with quantity and quality of liver regeneration (time frame: measurements will be taken pre, then 4 hours and 24 hours post resection). 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 28 Oct 2026.