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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00827723
Recruitment Status : Unknown
Verified January 2016 by Nicolas DEMARTINES, University of Lausanne Hospitals.
Recruitment status was:  Recruiting
First Posted : January 23, 2009
Last Update Posted : January 28, 2016
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals

Brief Summary:

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.

Condition or disease
Carcinoma, Hepatocellular Alcoholic Cirrhosis Viral Cirrhosis Postoperative Hepatic Failure

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official 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?
Study Start Date : February 2009
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Alcoholic cirrhotic patient with resectable hepatocellular carcinoma
Viral cirrhotic patient with resectable hepatocellular carcinoma

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. postoperative liver failure. [ Time Frame: 1 year ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00827723

Contact: Diana Michele, MD 0041213142369
Contact: Halkic Nermin, PD MER 0041213142248

Centre Hospitalier Universitaire Vaudois (CHUV) Recruiting
Lausanne, Vaud, Switzerland, 1005
Contact: Diana Michele, MD    +41213142369 ext 0793618939   
Contact: Halkic Nermin, PD    +41213142248   
Principal Investigator: Diana Michele, MD         
Principal Investigator: Halkic Nermin, PD         
Sponsors and Collaborators
University of Lausanne Hospitals
Principal Investigator: Diana Michele, MD CHUV University Hospital of Lausanne
Study Director: Halkic Nermin, PD CHUV University Hospital of Lausanne
Study Chair: Demartines Nicolas, Professeur CHUV University Hospitals of Lausanne

Responsible Party: Nicolas DEMARTINES, professor of surgery, University of Lausanne Hospitals Identifier: NCT00827723     History of Changes
Other Study ID Numbers: 251/08
First Posted: January 23, 2009    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Nicolas DEMARTINES, University of Lausanne Hospitals:
Hepatic functional reserve
Hepatocellular carcinoma (HCC)
Indocyanine Green retention rate at 15 minutes (ICG-R15')
Portal Pressure (PP)
Hepatic Portal Venous Gradient (HPVG)
Alcoholic and Viral Cirrhosis
Makuuchi criteria
Barcelona Clinic of Liver Cancer (BCLC)
Hepatic resection

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Cirrhosis
Liver Failure
Liver Cirrhosis, Alcoholic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Pathologic Processes
Hepatic Insufficiency
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders