Indocyanine Green and Portal Pressure in Viral and Alcoholic Cirrhotic Patients With Hepatocarcinoma

The aim of the investigators' study is to elucidate the relationship between a functional liver test (e.g., ICG) and the PREOPERATIVE value of portal hypertension in the patients with impaired liver function from alcoholic and non-alcoholic aetiologies. Alcoholic and viral cirrhosis present important differences in terms of cellular mechanisms responsible for the disease progression with a distinct and unique gene expression pattern that regulates the type of inflammatory response. These differences probably influence the hepatic functional reserve and the onset of portal hypertension at a comparable clinical and biological level of derangement and the investigators may expect significant differences in the recovery from hepatectomy.

The investigators' hypothesis is that at a comparable ICGR-15 rate non-viral cirrhotic liver presents higher portal pressure values and the investigators also argue that alcoholic cirrhotic patients would tolerate a larger hepatic resection than would viral cirrhotic do.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Alcohol-Induced Disorders Alcohol-Related Disorders Alcoholic Cirrhosis Carcinoma Chemically-Induced Disorders Digestive System Diseases Digestive System Neoplasms Fibrosis Liver Cirrhosis Liver Cirrhosis, Alcoholic Liver Diseases Liver Diseases, Alcoholic Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Hepatic Failure Substance-Related Disorders Viral Cirrhosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1005, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

resectable or amenable to resection HCC in cirrhotic child A patients of alcoholic or viral etiology

Exclusion criteria

cirrhosis Child-Pugh B
absence of patient consent
psychiatric pathology

Treatment and study plan

Primary outcomes

concordance rate between ICGR-15 and Portal Pressure values in patients with resectable HCC and cirrhosis Child A from alcoholic and non-alcoholic origin.

Time frame: 1 year

Secondary outcomes

postoperative liver failure.

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Official study title

Makuuchi Versus Barcelona Clinic of Liver Cancer Criteria in Cirrhotic Patients With Hepatocellular Carcinoma. Does Etiology of Cirrhosis Influence the Relationship Between the Portal Pressure and Quantitative Tests of Liver Function?

Important dates

Study start: 2009
Primary completion: 2018
Study completion: 2018
First posted: Jan 23, 2009
Registry last updated: Nov 13, 2018

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.

Published trials that share one or more normalized conditions with this study.

Completed