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

This study is currently recruiting participants.
Verified April 2012 by University of Lausanne Hospitals
Sponsor:
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00827723
First received: January 22, 2009
Last updated: April 21, 2012
Last verified: April 2012
History of Changes
  Purpose

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
Carcinoma, Hepatocellular
Alcoholic Cirrhosis
Viral Cirrhosis
Postoperative Hepatic Failure

Study Type: Observational
Study Design: 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?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • postoperative liver failure. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Alcoholic
Alcoholic cirrhotic patient with resectable hepatocellular carcinoma
Viral
Viral cirrhotic patient with resectable hepatocellular carcinoma

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827723

Contacts
Contact: Diana Michele, MD 0041213142369 michelediana@virgilio.it
Contact: Halkic Nermin, PD MER 0041213142248 Nermin.Halkic@chuv.ch

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV) Recruiting
Lausanne, Vaud, Switzerland, 1005
Contact: Diana Michele, MD     +41213142369 ext 0793618939     michelediana@virgilio.it    
Contact: Halkic Nermin, PD     +41213142248     Nermin.Halkic@chuv.ch    
Principal Investigator: Diana Michele, MD            
Principal Investigator: Halkic Nermin, PD            
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
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
  More Information

Publications:

Responsible Party: Nicolas DEMARTINES, professor of surgery, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT00827723     History of Changes
Other Study ID Numbers: 251/08
Study First Received: January 22, 2009
Last Updated: April 21, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by 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
Liver Cirrhosis
Fibrosis
Liver Cirrhosis, Alcoholic
Liver Neoplasms
Liver Failure
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
 Digestive System Diseases
Pathologic Processes
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Digestive System Neoplasms
Neoplasms by Site
Hepatic Insufficiency
Adenocarcinoma

ClinicalTrials.gov processed this record on May 23, 2013