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

NCT04195438 | Completed Results DMC FDA Device

• 1 other identifier: HP-00054854
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cancer

Keywords

Hepatectomy; Hepatic Regeneration; Arterial Blood Gas; CO Production

Outcome Measures

Primary Outcomes (6)

• CO Output (Ppm)

  Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection

  Baseline

• ABG (COHb)

  Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection

  Baseline

• CO Output (Ppm)

  Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection

  4 hours post resection

• ABG (COHb)

  Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection

  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

  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

  24 hours post resection

Secondary Outcomes (1)

• Volume (ml)

  One month after PH and liver function tests

Study Arms (1)

Intervention Arm

OTHER

CO and ABG Testing Arm

Procedure: CO Testing Pre/Post Hepatic Resection; Diagnostic Test: ABG Testing Pre/Post Hepatic Resection; Diagnostic Test: CT Evaluations

Interventions

CO Testing Pre/Post Hepatic Resection PROCEDURE

Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH

Intervention Arm

ABG Testing Pre/Post Hepatic Resection DIAGNOSTIC_TEST

Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH

Intervention Arm

CT Evaluations DIAGNOSTIC_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

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Baltimore Washington Medical Center

Glen Burnie, Maryland, 21601, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Cherif Boutros (Surgical Oncologist)
• Organization: University of Maryland School of Medicine

cboutros@som.umaryland.edu

410-328-7320

Study Officials

• Cherif Boutros, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There is no randomization, every patient gets CO testing and ABG measurements to assess liver regeneration.

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: December 11, 2019
• Study Start: May 7, 2014
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: June 21, 2024
• Results First Posted: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 12 months post study completion
• Access Criteria: clinicaltrials.gov

Locations

US (1)