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

November 9, 2018 updated by: Nicolas DEMARTINES, University of Lausanne Hospitals

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?

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1005
        • Centre Hospitalier Universitaire Vaudois (CHUV)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Alcoholic
Alcoholic cirrhotic patient with resectable hepatocellular carcinoma
Viral
Viral cirrhotic patient with resectable hepatocellular carcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
postoperative liver failure.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2009

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

January 22, 2009

First Submitted That Met QC Criteria

January 22, 2009

First Posted (Estimate)

January 23, 2009

Study Record Updates

Last Update Posted (Actual)

November 13, 2018

Last Update Submitted That Met QC Criteria

November 9, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 251/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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