Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy

July 18, 2025 updated by: Englewood Hospital and Medical Center

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 (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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient plans to have partial liver resection for primary liver pathology or metastatic disease
  • Patient is able to comprehend and willing to sign the written consent form

Exclusion Criteria:

  • Patients < 18 years
  • Patients identified as members of a vulnerable population, except women of child bearing potential with negative pregnancy test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: all participants
all participants will provide breath samples to detect carbon monoxide levels
Other: carbon monoxide measurement via smokerlyzer
participants in this study will provide breath samples for carbon monoxide measurements pre and post liver resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
measurements will be taken pre, then 4 hours and 24 hours post resection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of carbon monoxide in exhaled air of patients
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
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
CT liver volumetric studies
one and three months after resection
quality of hepatic regeneration, normalized liver function
Time Frame: one and three months post resection
serum protein, albumin, AST and ALT, alkaline phosphatase, and bilirubin level
one and three months post resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Englewood Hospital and Medical Center

Investigators

  • Principal Investigator: Cherif Boutros, MD, Englewood Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 21, 2025

Primary Completion (Estimated)

January 1, 2039

Study Completion (Estimated)

January 1, 2039

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 7, 2024

First Posted (Actual)

November 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 18, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-24-982

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Regeneration

Clinical Trials on carbon monoxide measurement via smokerlyzer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe