Compensated Cirrhosis
Conditions
Keywords
Cirrhosis, Hepatocellular carcinoma, Screening, Randomized, HBV, HCV, alcohol, hemochromatosis
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).
Interventions
PROCEDUREUltrasonographic screening
Ultrasonographic screening
Sponsors
Ministry of Health, France
UNICANCER
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of small hepatocellular carcinoma (HCC) | 6 months versus 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Survival | during the study |
| Clinical value of serum alfa-fetoprotein assay | during the study |
Countries
France
Outcome results
None listed