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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06681818
Enrollment
125
Registered
2024-11-08
Start date
2025-11-21
Completion date
2039-01-01
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer Adult, Liver Regeneration

Keywords

hepatectomy

Brief 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 (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.

Interventions

OTHERcarbon monoxide measurement via smokerlyzer

participants in this study will provide breath samples for carbon monoxide measurements pre and post liver resection

Sponsors

Englewood Hospital and Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
correlation of carbon monoxide levels in exhaled breath with quantity and quality of liver regenerationmeasurements will be taken pre, then 4 hours and 24 hours post resectionpatients will be asked to donate exhaled breath into a smokerlyzer device

Secondary

MeasureTime frameDescription
level of carbon monoxide in exhaled air of patientsmeasurements will be taken pre, then 4 hours and 24 hours post resectionpatients will be asked to donate exhaled breath into a smokerlyzer device
quantity of liver regeneration, liver volume (ml)one and three months after resectionCT liver volumetric studies
quality of hepatic regeneration, normalized liver functionone and three months post resectionserum protein, albumin, AST and ALT, alkaline phosphatase, and bilirubin level

Countries

United States

Contacts

Primary ContactJamie Ketas
jamie.ketas@ehmchealth.org2018943418
Backup ContactRaquel Molina
raquel.molina@ehmchealth.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026