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NCT Number: NCT04195438

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

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.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland Baltimore Washington Medical Center

Glen Burnie, Maryland, 21601, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

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

Primary outcomes

  1. CO Output (Ppm)

    Time frame: Baseline

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

  2. ABG (COHb)

    Time frame: Baseline

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

  3. CO Output (Ppm)

    Time frame: 4 hours post resection

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

  4. ABG (COHb)

    Time frame: 4 hours post resection

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

  5. CO Output (Ppm)

    Time frame: 24 hours post resection

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

  6. ABG (COHb)

    Time frame: 24 hours post resection

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

Secondary outcomes

  1. Volume (ml)

    Time frame: One month after PH and liver function tests

    Measure the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Dec 11, 2019
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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