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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Other | CO and ABG Testing Arm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Volume (ml) | Measure the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration | One month after PH and liver function tests |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cherif Boutros, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Baltimore Washington Medical Center | Glen Burnie | Maryland | 21601 | United States |
Aggregate data once data is analyzed and available when the study endpoints are completed patient enrollment is completed.
12 months post study completion
clinicaltrials.gov
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | CO and ABG Testing Arm CO Testing Pre/Post Hepatic Resection: Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH ABG Testing Pre/Post Hepatic Resection: Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH CT Evaluations: 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2023 |
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There is no randomization, every patient gets CO testing and ABG measurements to assess liver regeneration.
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| 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 |
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| 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 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | CO and ABG Testing Arm CO Testing Pre/Post Hepatic Resection: Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH ABG Testing Pre/Post Hepatic Resection: Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH CT Evaluations: 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CO Output (Ppm) | Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection | Posted | Mean | Standard Deviation | ppm | Baseline |
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| Primary | ABG (COHb) | Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection | Posted | Mean | Full Range | percentage of Carboxyhemoglobin | Baseline |
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| Primary | CO Output (Ppm) | Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection | Posted | Mean | Standard Deviation | ppm | 4 hours post resection |
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| Primary | ABG (COHb) | Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection | Posted | Mean | Full Range | percentage of Carboxyhemoglobin | 4 hours post resection |
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| Primary | CO Output (Ppm) | Measure the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection | Posted | Mean | Standard Deviation | ppm | 24 hours post resection |
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| Primary | ABG (COHb) | Measure the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection | Posted | Mean | Full Range | percentage of Carboxyhemoglobin | 24 hours post resection |
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| Secondary | Volume (ml) | Measure the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration | Posted | Mean | Standard Deviation | ml | One month after PH and liver function tests |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm | CO and ABG Testing Arm CO Testing Pre/Post Hepatic Resection: Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH ABG Testing Pre/Post Hepatic Resection: Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH CT Evaluations: 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 | 0 | 25 | 0 | 25 | 0 | 25 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cherif Boutros (Surgical Oncologist) | University of Maryland School of Medicine | 410-328-7320 | cboutros@som.umaryland.edu |
| Jun 14, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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