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

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Recruiting
CT.gov ID
NCT04195438
Collaborator
(none)
30
1
1
127.8
0.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: CO Testing Pre/Post Hepatic Resection
  • Diagnostic Test: ABG Testing Pre/Post Hepatic Resection
  • Diagnostic Test: CT Evaluations
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
There is no randomization, every patient gets CO testing and ABG measurements to assess liver regeneration.There is no randomization, every patient gets CO testing and ABG measurements to assess liver regeneration.
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
May 7, 2014
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Intervention Arm

CO and ABG Testing Arm

Procedure: CO Testing Pre/Post Hepatic Resection
Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH

Diagnostic Test: 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

Diagnostic Test: 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

Outcome Measures

Primary Outcome Measures

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

    CO Output (ppm)

  2. Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection [Baseline]

    ABG (COHb)

  3. Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection [4 hours post resection]

    CO Output (ppm)

  4. Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection [4 hours post resection]

    ABG (COHb)

  5. Measure the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection [24 hours post resection]

    CO Output (ppm)

  6. 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)

Secondary Outcome Measures

  1. Measure the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration [One month after PH and liver function tests]

    Volume (ml)

  2. Measure the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration [Three months after PH and liver function tests]

    Volume (ml)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Maryland Baltimore Washington Medical Center Glen Burnie Maryland United States 21601

Sponsors and Collaborators

  • University of Maryland, Baltimore

Investigators

  • Principal Investigator: Cherif Boutros, MD, University of Maryland, Baltimore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT04195438
Other Study ID Numbers:
  • HP-00054854
First Posted:
Dec 11, 2019
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Keywords provided by University of Maryland, Baltimore
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2022