Clinical trial NCT00190385: Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Compensated Cirrhosis
Keywords: Cirrhosis
Hepatocellular carcinoma
Screening
Randomized
HBV
HCV
alcohol
hemochromatosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: UNICANCER
First posted: 2005-09-19
Enrollment: 1200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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).

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of small hepatocellular carcinoma (HCC)
timeFrame: 6 months versus 3 months
Secondary outcomes:
measure: Survival
timeFrame: during the study
measure: Clinical value of serum alfa-fetoprotein assay
timeFrame: during the study
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Jean Verdier
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Claude Trinchet, Pr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ganne-Carrie N, Nahon P, Chaffaut C, N'Kontchou G, Layese R, Audureau E, Chevret S; CIRRAL group; ANRS CO12 CirVir group. Impact of cirrhosis aetiology on incidence and prognosis of hepatocellular carcinoma diagnosed during surveillance. JHEP Rep. 2021 Mar 26;3(3):100285. doi: 10.1016/j.jhepr.2021.100285. eCollection 2021 Jun.
citation: Nery F, Chevret S, Condat B, de Raucourt E, Boudaoud L, Rautou PE, Plessier A, Roulot D, Chaffaut C, Bourcier V, Trinchet JC, Valla DC; Groupe d'Etude et de Traitement du Carcinome Hepatocellulaire. Causes and consequences of portal vein thrombosis in 1,243 patients with cirrhosis: results of a longitudinal study. Hepatology. 2015 Feb;61(2):660-7. doi: 10.1002/hep.27546. Epub 2015 Jan 5.
citation: Trinchet JC, Chaffaut C, Bourcier V, Degos F, Henrion J, Fontaine H, Roulot D, Mallat A, Hillaire S, Cales P, Ollivier I, Vinel JP, Mathurin P, Bronowicki JP, Vilgrain V, N'Kontchou G, Beaugrand M, Chevret S; Groupe d'Etude et de Traitement du Carcinome Hepatocellulaire (GRETCH). Ultrasonographic surveillance of hepatocellular carcinoma in cirrhosis: a randomized trial comparing 3- and 6-month periodicities. Hepatology. 2011 Dec;54(6):1987-97. doi: 10.1002/hep.24545.