Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis

Phase 3

Completed

• Conditions: Compensated Cirrhosis
• Interventions: Procedure: Ultrasonographic screening

• Registration Number: NCT00190385
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2000-07
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-19
• Status Verified: 2007-03
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Last Update Submitted: 2011-02-24
• Last Update Posted: 2011-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Compensated cirrhosis

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
A	Ultrasonographic screening	-

Primary Outcome Measures

Name	Time	Method
Incidence of small hepatocellular carcinoma (HCC)	6 months versus 3 months

Secondary Outcome Measures

Name	Time	Method
Survival	during the study
Clinical value of serum alfa-fetoprotein assay	during the study

Trial Locations

Locations (1)

Hopital Jean Verdier; 🇫🇷 Paris, Ile de France, France