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

This study is currently recruiting participants.
Verified January 2016 by Nicolas DEMARTINES, University of Lausanne Hospitals
Sponsor:
ClinicalTrials.gov Identifier:
NCT00827723
First Posted: January 23, 2009
Last Update Posted: January 28, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Nicolas DEMARTINES, University of Lausanne Hospitals
  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:


Further study details as provided by Nicolas DEMARTINES, 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 ]

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

Estimated Enrollment: 60
Study Start Date: February 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 22, 2009
First Posted: January 23, 2009
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
Carcinoma
Fibrosis
Liver Cirrhosis
Liver Failure
Liver Cirrhosis, Alcoholic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
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


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