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
1 other identifier
interventional
125
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2024
CompletedFirst Posted
Study publicly available on registry
November 8, 2024
CompletedStudy Start
First participant enrolled
November 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2039
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2039
July 23, 2025
November 1, 2024
13.1 years
November 6, 2024
July 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
measurements will be taken pre, then 4 hours and 24 hours post resection
quantity of liver regeneration, liver volume (ml)
one and three months after resection
quality of hepatic regeneration, normalized liver function
one and three months post resection
Study Arms (1)
all participants
EXPERIMENTALall participants will provide breath samples to detect carbon monoxide levels
Interventions
participants in this study will provide breath samples for carbon monoxide measurements pre and post liver resection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients \< 18 years
- Patients identified as members of a vulnerable population, except women of child bearing potential with negative pregnancy test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Englewood Hospital
Englewood, New Jersey, 07631, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cherif Boutros, MD
Englewood Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2024
First Posted
November 8, 2024
Study Start
November 21, 2025
Primary Completion (Estimated)
January 1, 2039
Study Completion (Estimated)
January 1, 2039
Last Updated
July 23, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share