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Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis (CHIC)

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: NCT00848952
Recruitment Status : Unknown
Verified February 2009 by University Hospital, Angers.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2009
Last Update Posted : February 4, 2010
Information provided by:
University Hospital, Angers

February 20, 2009
February 23, 2009
February 4, 2010
March 2009
March 2010   (Final data collection date for primary outcome measure)
Report of proportion of the positives truths and the positive wrong for an examination [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT00848952 on Archive Site
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Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis
Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis
The purpose of this study is to evaluate 3 imaging techniques and their associations : MRI, CTscanner and enhanced contrast ultrasound for the diagnosis of small (< 3 cm) hepatocellular carcinoma for patients with cirrhosis.

With the improvement of cirrhosis complications coverage, hepatocellular carcinoma (HCC) tend to become the main cause of mortality for cirrhotic patients. Currently, the incidence of the HCC increase in occidental country and hid global prognostic remain very bad. The main indication factor for a curative treatment is the size lesion.

Cirrhosis is the main risk factor for HCC occurence. In France, HCC screening has been establish for cirrhotic patients with hepatic ultrasound and alfa-fetoprotein measurement with the aim of detected HCC when the size allows a curative treatment.

When a nodule is discovered during the follow-up, HCC diagnosis is done following the recommendations of European Association for the Study of the Liver (AESL) in 2000, updated by the American Association for the Study of Liver Diseases (AASLD)in 2005. Diagnostic is function of nodule feature on one or two enhanced imaging techniques among CTscanner, MRI and enhanced contrast ultrasound.

This diagnostic strategy raises several questions. First, neither the most efficient dynamic imaging association for nodules from 1 to 2 cm, nor the most efficient imaging examination for nodules from 2 to 3 cm are known. Second, only few studies have been carried out about imaging semiology of the small hepatocellular carcinoma. Thus, the imprecisions of the present recommendations regarding the choice of the best examination technique and the difficulties in the diagnosis of benign or malignant nature for small nodule can lead to a bad management of these patients.

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Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Hepatocellular Carcinoma
Other: 3 imaging techniques are done
all patients have : MRI, CTscanner, enhanced contrast ultrasound
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • age > 18 hears
  • presence of one or several nodules < 3 cm
  • known or suspected cirrhosis

Exclusion Criteria:

  • psychiatric disease
  • contraindication to one of the 3 imaging examinations (CTscanner, MRI, enhanced contrast ultrasound
  • patient already treated by chemoembolization
  • recurrence on the coagulation zone of a nodule already treated by per-cutaneous tumour destruction
  • presence of a tumour (> 3 cm) associated to the nodule
  • pregnant woman or breast-feeding woman
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
PHRC 2008-01
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Christophe Aubé, University Hospital Angers
University Hospital, Angers
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University Hospital, Angers
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP