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

Liver Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04195438
• Other study ID #: HP-00054854
• Status: Completed
• Phase: N/A
• Start date: May 7, 2014
• Est. completion date: March 26, 2024

Study information

• Verified date: June 2024
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 26, 2024
• Est. primary completion date: March 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Maryland Baltimore Washington Medical Center	Glen Burnie	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CO Output (Ppm)	Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection	Baseline
Primary	ABG (COHb)	Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection	Baseline
Primary	CO Output (Ppm)	Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection	4 hours post resection
Primary	ABG (COHb)	Measure HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection	4 hours post resection
Primary	CO Output (Ppm)	Measure the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection	24 hours post resection
Primary	ABG (COHb)	Measure the extent of HO-1 induction by measuring endogenous CO production in relationship to the extent of hepatic resection	24 hours post resection
Secondary	Volume (ml)	Measure the relationship between HO-1 induction and the quality of post-hepatectomy liver regeneration	One month after PH and liver function tests