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

Completed NA Results posted Last updated 21 June 2024

What this trial tests

NA trial testing CO Testing Pre/Post Hepatic Resection in Liver Cancer in 25 participants. Completed in 26 March 2024.

Timeline

7 May 2014

Primary endpoint
26 March 2024

26 March 2024

Quick facts

Lead sponsor	University of Maryland, Baltimore
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	25
Start date	7 May 2014
Primary completion	26 March 2024
Estimated completion	26 March 2024
Sites	1 location across United States

Drugs / interventions tested

• CO Testing Pre/Post Hepatic Resection
• ABG Testing Pre/Post Hepatic Resection
• CT Evaluations

Conditions studied

• Liver Cancer — all drugs for Liver Cancer →

Sponsor

University of Maryland, Baltimore

Who can join

18 and older, any sex, with Liver Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

CO Output (Ppm) Primary · Baseline

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

Group	Value	95% CI
Intervention Arm	2.03	± 0.82

ABG (COHb) Primary · Baseline

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

Group	Value	95% CI
Intervention Arm	1.58	0.5 – 6.2

CO Output (Ppm) Primary · 4 hours post resection

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

Group	Value	95% CI
Intervention Arm	3.11	± 1.42

ABG (COHb) Primary · 4 hours post resection

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

Group	Value	95% CI
Intervention Arm	1.41	0.4 – 2.8

CO Output (Ppm) Primary · 24 hours post resection

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

Group	Value	95% CI
Intervention Arm	3.00	± 1.41

ABG (COHb) Primary · 24 hours post resection

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

Group	Value	95% CI
Intervention Arm	1.54	0.9 – 2.3

Volume (ml) Secondary · One month after PH and liver function tests

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

Group	Value	95% CI
Intervention Arm	170	± 146

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Heme Oxygenase-1 in Gastrointestinal Tract Health and Disease.
   Puentes-Pardo JD, Moreno-SanJuan S, Carazo Á, León J. · · 2020 · cited 40× · PMID 33276470 · DOI 10.3390/antiox9121214