Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis. A Randomized Trial Comparing Two Periodicities of Ultrasonographic Surveillance: 3-month vs 6-month
30 Years
75 Years
Both
Compensated Cirrhosis
Trial Information
Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis. A Randomized Trial Comparing Two Periodicities of Ultrasonographic Surveillance: 3-month vs 6-month
Patients: All consecutive patients with compensated HBV, HCV, alcohol or
hemochromatosis-related cirrhosis (without any previous clinical complication including
liver cancer).
Randomization: factorial: ultrasonography (3-month versus 6-month); serum alfa-fetoprotein
assay (none versus 6-month).
End points: rate of small tumors (first main criteria); survival (second main criteria).
Inclusion Criteria:
- Compensated cirrhosis
Exclusion Criteria:
- Antecedent of osmic acid synoviorthesis or of isotopic synoviorthesis of the studied
knee
- Intra-articular injection of triamcinolone hexacetonide in three months preceding the
inclusion or by a different corticoid in the month preceding the inclusion
- Evolutionary infectious or neoplastic pathology
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label
Outcome Measure:
Incidence of small hepatocellular carcinoma (HCC)
Outcome Time Frame:
6 months versus 3 months
Safety Issue:
Yes
Principal Investigator
Jean-Claude Trinchet, Pr, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Assistance Publique - Hôpitaux de Paris
Authority:
France: Ministry of Health
Study ID:
AOM03009
NCT ID:
NCT00190385
Start Date:
July 2000
Completion Date:
July 2009
Related Keywords:
- Compensated Cirrhosis
- Cirrhosis
- Hepatocellular carcinoma
- Screening
- Randomized
- HBV
- HCV
- alcohol
- hemochromatosis
- Carcinoma
- Liver Cirrhosis
- Fibrosis
- Carcinoma, Hepatocellular
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