NCT00190385

Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis

Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis. A Randomized Trial Comparing Two Periodicities of Ultrasonographic Surveillance: 3-month vs 6-month

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Compensated Cirrhosis

Interventions

Type	Name	Description
PROCEDURE	Ultrasonographic screening	Ultrasonographic screening

Timeline

• Start date: 2000-07-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2005-09-19
• Last updated: 2011-02-25

Locations

1 site across 1 country: France