Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Compensated Cirrhosis

Treatments: Procedure: Ultrasonographic screening

Study type: Interventional

Funder types: Other

Identifiers

NCT00190385

AOM03009

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,200 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,200 participants in 1 patient group

A

Active Comparator group

Treatment:

Procedure: Ultrasonographic screening