Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis
Liver carcinoma is becoming the main complication of cirrhosis. Treatment of symptomatic or large tumors is disappointing. Regular ultrasonographic screening of small (curable) tumors is currently recommended, but the best periodicity is unknown.This randomized trial is aimed to compare 6-month (current recommendation) and 3-month ultrasonographic screenings.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
|Official Title:||Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis. A Randomized Trial Comparing Two Periodicities of Ultrasonographic Surveillance: 3-month vs 6-month|
- Incidence of small hepatocellular carcinoma (HCC) [ Time Frame: 6 months versus 3 months ] [ Designated as safety issue: Yes ]
- Survival [ Time Frame: during the study ] [ Designated as safety issue: No ]
- Clinical value of serum alfa-fetoprotein assay [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2000|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: A||
Procedure: Ultrasonographic screening
Other Name: Ultrasonographic screening
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190385
|Hopital Jean Verdier|
|Paris, Ile de France, France, 75010|
|Principal Investigator:||Jean-Claude Trinchet, Pr, MD, PhD||Assistance Publique - Hôpitaux de Paris|