Postoperative Heme Oxygenase Induction and Carbon Monoxide Production as a Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy
Primary Purpose
Liver Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CO Testing Pre/Post Hepatic Resection
ABG Testing Pre/Post Hepatic Resection
CT Evaluations
Sponsored by
About this trial
This is an interventional other trial for Liver Cancer focused on measuring Hepatectomy, Hepatic Regeneration, Arterial Blood Gas, CO Production
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients age less than 18
- Patients not having pathology proven liver malignancy
- Patient not able to comprehend or sign written consent form.
Sites / Locations
- University of Maryland Baltimore Washington Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention Arm
Arm Description
CO and ABG Testing Arm
Outcomes
Primary Outcome Measures
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
CO Output (ppm)
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
ABG (COHb)
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
CO Output (ppm)
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
ABG (COHb)
Measure the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
CO Output (ppm)
Measure the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
ABG (COHb)
Secondary Outcome Measures
Measure the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration
Volume (ml)
Measure the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration
Volume (ml)
Full Information
NCT ID
NCT04195438
First Posted
November 20, 2019
Last Updated
March 28, 2023
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT04195438
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2014 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
Hepatectomy, Hepatic Regeneration, Arterial Blood Gas, CO Production
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
There is no randomization, every patient gets CO testing and ABG measurements to assess liver regeneration.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Other
Arm Description
CO and ABG Testing Arm
Intervention Type
Procedure
Intervention Name(s)
CO Testing Pre/Post Hepatic Resection
Intervention Description
Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH
Intervention Type
Diagnostic Test
Intervention Name(s)
ABG Testing Pre/Post Hepatic Resection
Intervention Description
Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH
Intervention Type
Diagnostic Test
Intervention Name(s)
CT Evaluations
Intervention Description
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
Primary Outcome Measure Information:
Title
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Description
CO Output (ppm)
Time Frame
Baseline
Title
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Description
ABG (COHb)
Time Frame
Baseline
Title
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Description
CO Output (ppm)
Time Frame
4 hours post resection
Title
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Description
ABG (COHb)
Time Frame
4 hours post resection
Title
Measure the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Description
CO Output (ppm)
Time Frame
24 hours post resection
Title
Measure the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Description
ABG (COHb)
Time Frame
24 hours post resection
Secondary Outcome Measure Information:
Title
Measure the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration
Description
Volume (ml)
Time Frame
One month after PH and liver function tests
Title
Measure the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration
Description
Volume (ml)
Time Frame
Three months after PH and liver function tests
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Patients age less than 18
Patients not having pathology proven liver malignancy
Patient not able to comprehend or sign written consent form.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
McKenzie E Bedra
Phone
410-553-8184
Email
McKenzie.Bedra@umm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Emel
Phone
410-553-8048
Email
Jennifer.Emel@umm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cherif Boutros, MD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Baltimore Washington Medical Center
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
McKenzie Bedra
Phone
410-553-8184
Email
McKenzie.Bedra@umm.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Emel
Phone
410-553-8048
Email
Jennifer.Emel@umm.edu
First Name & Middle Initial & Last Name & Degree
Cherif Boutros, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Aggregate data once data is analyzed and available when the study endpoints are completed patient enrollment is completed.
IPD Sharing Time Frame
12 months post study completion
IPD Sharing Access Criteria
clinicaltrials.gov
Learn more about this trial
Postoperative Heme Oxygenase Induction and Carbon Monoxide Production as a Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy
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