Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Keywords: Hepatectomy
Hepatic Regeneration
Arterial Blood Gas
CO Production
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: There is no randomization, every patient gets CO testing and ABG measurements to assess liver regeneration.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: CO Output (Ppm)
timeFrame: Baseline
measure: ABG (COHb)
timeFrame: Baseline
measure: CO Output (Ppm)
timeFrame: 4 hours post resection
measure: ABG (COHb)
timeFrame: 4 hours post resection
measure: CO Output (Ppm)
timeFrame: 24 hours post resection
measure: ABG (COHb)
timeFrame: 24 hours post resection
Secondary outcomes:
measure: Volume (ml)
timeFrame: One month after PH and liver function tests
Other outcomes:
Locations:
city: Glen Burnie
country: United States
facility: University of Maryland Baltimore Washington Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Cherif Boutros, MD
role: PRINCIPAL_INVESTIGATOR
References: