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

University of Maryland Baltimore (UMB) logo

University of Maryland Baltimore (UMB)

Status

Completed

Conditions

Liver Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04195438
HP-00054854

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Intervention Arm
Other group
Description:
CO and ABG Testing Arm
Treatment:
Diagnostic Test: CT Evaluations
Diagnostic Test: ABG Testing Pre/Post Hepatic Resection
Procedure: CO Testing Pre/Post Hepatic Resection

Trial documents
1

Trial contacts and locations

1

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Central trial contact

McKenzie E Bedra; Jennifer Emel

Data sourced from clinicaltrials.gov

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