Liver Cancer
Conditions
Keywords
Hepatectomy, Hepatic Regeneration, Arterial Blood Gas, CO Production
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.
Interventions
PROCEDURECO Testing Pre/Post Hepatic Resection
Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH
DIAGNOSTIC_TESTABG 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
DIAGNOSTIC_TESTCT 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
Sponsors
University of Maryland, Baltimore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
There is no randomization, every patient gets CO testing and ABG measurements to assess liver regeneration.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CO Output (Ppm) | Baseline | Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection |
| ABG (COHb) | Baseline | Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume (ml) | One month after PH and liver function tests | Measure the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Intervention Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 64 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
ABG (COHb)
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Time frame: 4 hours post resection
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Arm | ABG (COHb) | 1.41 percentage of Carboxyhemoglobin |
Primary
ABG (COHb)
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Time frame: Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Arm | ABG (COHb) | 1.58 percentage of Carboxyhemoglobin |
Primary
ABG (COHb)
Measure the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Time frame: 24 hours post resection
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Arm | ABG (COHb) | 1.54 percentage of Carboxyhemoglobin |
Primary
CO Output (Ppm)
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | CO Output (Ppm) | 2.03 ppm | Standard Deviation 0.82 |
Primary
CO Output (Ppm)
Measure the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Time frame: 24 hours post resection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | CO Output (Ppm) | 3.00 ppm | Standard Deviation 1.41 |
Primary
CO Output (Ppm)
Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection
Time frame: 4 hours post resection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | CO Output (Ppm) | 3.11 ppm | Standard Deviation 1.42 |
Secondary
Volume (ml)
Measure the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration
Time frame: One month after PH and liver function tests
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Volume (ml) | 170 ml | Standard Deviation 146 |