Liver CancerNCT04195438

Postoperative Heme Oxygenase Induction and Carbon Monoxide Production as a Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy

A study testing CO Testing Pre/Post Hepatic Resection, ABG Testing Pre/Post Hepatic Resection and CT Evaluations in people with Liver Cancer, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Liver Cancer
What is being tested?: CO Testing Pre/Post Hepatic Resection, ABG Testing Pre/Post Hepatic Resection and CT Evaluations
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 7 May 2014to 26 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients plan to have partial liver resection for primary liver pathology or metastatic disease.
Patients able to comprehend and willing to sign the written consent form.

Who cannot join

Patients age less than 18
Patients not having pathology proven liver malignancy
Patient not able to comprehend or sign written consent form.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Maryland Baltimore Washington Medical Center
Glen Burnie, Maryland, 21601

Other trials in United States

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-1301GCC

The study will monitor carbon monoxide production in patients undergoing liver resection. Carbon monoxide will be checked from arterial blood gas obtained routinely as a part of the postoperative care as well as from the exhaled air of the patient through a CO detector commercially available and used as smokerlyzer helping people to stop smoking. The results of the surgical resection will be collected from the patient routinely ordered tests after liver resection including pathology of the resected part of the liver, laboratory and radiology tests. The study aims to identify the relationship between CO production and recovery after liver resection. Results of this study may help in predicting and improving results of liver resection.

Read the detailed description

The goal of this proposal is to elucidate the role of HO-1 induction in hepatic regeneration after partial hepatectomy (PH). There is a growing body of evidence that HO-1 induction through CO production has an important role in cellular protection and regeneration. To test this concept, we will monitor endogenous CO production in patients who undergo PH and analyze the relationship between CO production and hepatic regeneration. Using this approach we will test the following two hypotheses: (1) HO-1 induction after PH is proportional to the extent of the surgical resection, and (2) failure to appropriately induce HO-1 is associated with impaired hepatic regeneration.

Specific Aim 1: To monitor the extent of HO-1 induction (by measuring endogenous CO production) in relationship to the extent of hepatic resection 1.1 Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH 1.2 Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH 1.3 Analyze the relationship between CO production and the extent of hepatic resection assessed by computed scans liver volumetric study at one and three months after PH, size and weight of the resected specimen and operative report.

Specific Aim 2: To analyze the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration after PH 2.1 Analyze the relationship between CO production and the quantity and quality of hepatic regeneration assessed by computed scans liver volumetric study at one and three months after PH and liver function tests after PH.

2.2 Determine the relation between postoperative liver related morbidity in patients undergoing PH and the extent of postoperative HO-1 induction.

Conditions: Liver Cancer
Being tested: CO Testing Pre/Post Hepatic Resection, ABG Testing Pre/Post Hepatic Resection, CT Evaluations
Keywords: Hepatectomy, Hepatic Regeneration, Arterial Blood Gas, CO Production
Medical subject headings: Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CO Testing Pre/Post Hepatic ResectionProcedure or surgery
Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH
ABG Testing Pre/Post Hepatic ResectionDiagnostic test
Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH
CT EvaluationsDiagnostic test
Analyze the relationship between CO production and the extent of hepatic resection assessed by computed scans liver volumetric study at one and three months after PH, size and weight of the resected specimen and operative report

Study groups in NCT04195438
Study group	Role	What they receive
Intervention Arm	Other	CO and ABG Testing Arm Receives: Procedure: CO Testing Pre/Post Hepatic Resection; Diagnostic Test: ABG Testing Pre/Post Hepatic Resection; Diagnostic Test: CT Evaluations

What is being measured

The primary outcome is the main question the study is designed to answer.

CO Output (Ppm)
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Measured: Baseline
ABG (COHb)
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Measured: Baseline
CO Output (Ppm)
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Measured: 4 hours post resection
ABG (COHb)
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Measured: 4 hours post resection
CO Output (Ppm)
Measure the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Measured: 24 hours post resection
ABG (COHb)
Measure the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Measured: 24 hours post resection

Secondary outcomes (1)

Volume (ml)
Measure the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration
Measured: One month after PH and liver function tests

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 May 201426 Mar 2024

First posted11 Dec 2019
Study start7 May 2014
Primary completion26 Mar 2024
Study completion26 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Liver CancerStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe 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: Other
Allocation: Not applicable
Intervention model: Single group
Model description: There is no randomization, every patient gets CO testing and ABG measurements to assess liver regeneration.
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04195438
Sponsor's protocol ID: HP-00054854
Status last verified: Jun 2024
First submitted: 20 Nov 2019
Last updated: 21 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Aggregate data once data is analyzed and available when the study endpoints are completed patient enrollment is completed.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Liver Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2024. 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-1301GCC
ClinicalTrials.gov ID: NCT04195438
Acronym / sponsor ID: HP-00054854
Conditions: Liver Cancer
Keywords: Hepatectomy, Hepatic Regeneration, Arterial Blood Gas, CO Production
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Study start: 7 May 2014 (actual)
Primary completion: 26 Mar 2024 (actual)
Study completion: 26 Mar 2024 (actual)
First posted: 11 Dec 2019 (actual)
Results: Posted 21 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

2.2 Determine the relation between postoperative liver related morbidity in patients undergoing PH and the extent of postoperative HO-1 induction.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: There is no randomization, every patient gets CO testing and ABG measurements to assess liver regeneration.

Arm	Type	Receives
Intervention Arm	Other	Procedure: CO Testing Pre/Post Hepatic Resection, Diagnostic Test: ABG Testing Pre/Post Hepatic Resection, Diagnostic Test: CT EvaluationsCO and ABG Testing Arm

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients plan to have partial liver resection for primary liver pathology or metastatic disease.
Patients able to comprehend and willing to sign the written consent form.

Key exclusion criteria (3 listed)

Patients age less than 18
Patients not having pathology proven liver malignancy
Patient not able to comprehend or sign written consent form.

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
CO Testing Pre/Post Hepatic ResectionMonitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH	Procedure or surgery	Intervention Arm
ABG Testing Pre/Post Hepatic ResectionMonitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH	Diagnostic test	Intervention Arm
CT EvaluationsAnalyze the relationship between CO production and the extent of hepatic resection assessed by computed scans liver volumetric study at one and three months after PH, size and weight of the resected specimen and operative report	Diagnostic test	Intervention Arm

Primary outcome

CO Output (Ppm)
Time frame: Baseline
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
ABG (COHb)
Time frame: Baseline
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
CO Output (Ppm)
Time frame: 4 hours post resection
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
ABG (COHb)
Time frame: 4 hours post resection
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
CO Output (Ppm)
Time frame: 24 hours post resection
Measure the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
ABG (COHb)
Time frame: 24 hours post resection
Measure the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection

1 secondary outcome

Volume (ml)
Time frame: One month after PH and liver function tests

Results and safety

Results posted to the registry on 21 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Arm	25	24

Primary outcome: CO Output (Ppm)

Time frame: Baseline. Mean (Standard Deviation). Unit: ppm

Measure	Intervention Arm n = 24
Value	2.03 (0.82)

Primary outcome: ABG (COHb)

Time frame: Baseline. Mean (Full Range). Unit: percentage of Carboxyhemoglobin

Measure	Intervention Arm n = 24
Value	1.58 (0.5 to 6.2)

Primary outcome: CO Output (Ppm)

Time frame: 4 hours post resection. Mean (Standard Deviation). Unit: ppm

Measure	Intervention Arm n = 24
Value	3.11 (1.42)

Primary outcome: ABG (COHb)

Time frame: 4 hours post resection. Mean (Full Range). Unit: percentage of Carboxyhemoglobin

Measure	Intervention Arm n = 24
Value	1.41 (0.4 to 2.8)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Arm	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Limitations and caveats (from the sponsor): Lower enrollment than planned Further studies will be necessary to identify patient and liver factors that influence the induction of HO-1 as well as its potential beneficial effect on liver regeneration and patient outcomes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Aggregate data once data is analyzed and available when the study endpoints are completed patient enrollment is completed.

Related trials for Liver Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma

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.

Cherif Boutros, MD principal investigator

University of Maryland, Baltimore

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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: finished, as of the sponsor's last update on 21 Jun 2024. 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?

Yes. Results are posted in the registry (first posted 21 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CO Output (Ppm) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04195438.

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 21 Jun 2024.