Compensated Cirrhosis Clinical Trial
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
| Verified date | March 2007 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1200 |
| Est. completion date | July 2009 |
| Est. primary completion date | July 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | Hopital Jean Verdier | Paris | Ile de France |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Ministry of Health, France, UNICANCER |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of small hepatocellular carcinoma (HCC) | 6 months versus 3 months | Yes | |
| Secondary | Survival | during the study | No | |
| Secondary | Clinical value of serum alfa-fetoprotein assay | during the study | Yes |
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