Hepatobiliary Malignancies

Ultrasonographic surveillance of hepatocellular carcinoma in cirrhosis: A randomized trial comparing 3- and 6-month periodicities

Trinchet, Jean-Claude1,2,*c; Chaffaut, Cendrine3,4; Bourcier, Valérie1,2; Degos, Françoise5,6; Henrion, Jean7; Fontaine, Hélène8,9; Roulot, Dominique2,10; Mallat, Ariane11,12; Hillaire, Sophie13; Cales, Paul14; Ollivier, Isabelle15; Vinel, Jean-Pierre16; Mathurin, Philippe17; Bronowicki, Jean-Pierre18; Vilgrain, Valérie6,19,20; N'Kontchou, Gisèle1,2; Beaugrand, Michel1,2; Chevret, Sylvie3,4 for the Groupe d'Etude et de Traitement du Carcinome Hépatocellulaire (GRETCH)

Author Information

1AP-HP, Hôpital Jean Verdier, Service d'Hépato-gastroentérologie, Bondy, F-93140, France

2Université Paris 13 Paris-Nord, UFR SMBH, Bobigny, F-93000, France

3AP-HP, Hôpital Saint-Louis, DBIM, Paris, F-75010, France

4Inserm, Université Paris Diderot, UMR 717, Paris, F-75010, France

5AP-HP, Hôpital Beaujon, Service d'Hépatologie, Clichy, F-92110, France

6Université Paris 7 Denis-Diderot, Faculté de Médecine, Paris, F-75018, France

7Service d'Hépato-gastroentérologie, Hôpital de Jolimont, La Louvière (Haine-Saint-Paul), Belgique

8AP-HP, Hôpital Cochin, Service d'Hépatologie, Paris, F-75014, France

9Université Paris 5, Paris, F-75014, France

10AP-HP, Hôpital Avicenne, Unité d'Hépatologie, Bobigny, F-93000, France

11AP-HP, Hôpital Henri Mondor, Service d'Hépatologie, Créteil, F-94000, France

12Université Paris-Est Créteil, Créteil, F-94000, France

13Service d'Hépato-gastroentérologie, Hôpital Foch, Suresnes, France

14Service d'Hépato-gastroentérologie, CHU, Angers, France

15Service d'Hépato-gastroentérologie, CHU, Caen, France

16Service d'Hépato-gastroentérologie, CHU, Université de Toulouse, INSERM U858, Toulouse, France

17Service d'Hépato-gastroentérologie, CHU, Lille, France

18Service d'Hépato-gastroentérologie, CHU de Nancy, Vandœuvre, France

19AP-HP, Hôpital Beaujon, Service de Radiologie, Clichy, F-92110, France

20INSERM CRB3, Center de Recherche Biomédicale Bichat-Beaujon, Unité 773, Paris, F-75018, France

*Address reprint requests to: Service d'Hépato-gastroentérologie, Hôpital Jean Verdier, 93140 Bondy, France

Email:[email protected]

Potential conflict of interest: Dr. Bronowicki received grants from Gore and Schering–Plough.

Supported by grants from the French Ministry of Health (PHRC P980902 and P03009) and from the Ligue Nationale Contre le Cancer (Paris, France). The Promotor of the study was the Assistance Publique-Hôpitaux de Paris (Paris, France). ClinicalTrials.gov identifier: NCT00190385.

cfax: 33-1-48-02-62-02

Hepatology 54(6):p 1987-1997, December 2011. | DOI: 10.1002/hep.24545

Abstract

Detection of small hepatocellular carcinoma (HCC) eligible for curative treatment is increased by surveillance, but its optimal periodicity is still debated. Thus, this randomized trial compared two ultrasonographic (US) periodicities: 3 months versus 6 months. A multicenter randomized trial was conducted in France and Belgium (43 sites). Patients with histologically proven compensated cirrhosis were randomized into two groups: US every 6 months (Gr6M) or 3 months (Gr3M). For each focal lesion detected, diagnostic procedures were performed according to European Association for the Study of the Liver guidelines. Cumulative incidence of events was estimated, then compared using Gray's test. The prevalence of HCC ≤30 mm in diameter was the main endpoint. A sample size of 1,200 patients was required. A total of 1,278 patients were randomized (Gr3M, n = 640; Gr6M, n = 638; alcohol 39.2%, hepatitis C virus 44.1%, hepatitis B virus 12.5%). At least one focal lesion was detected in 358 patients (28%) but HCC was confirmed in only 123 (9.6%) (uninodular 58.5%, ≤30 mm in diameter 74%). Focal-lesion incidence was not different between Gr3M and Gr6M groups (2-year estimates, 20.4% versus 13.2%,P= 0.067) but incidence of lesions ≤10 mm was increased (41% in Gr3M versus 28% in Gr6M,P= 0.002). No difference in either HCC incidence (P= 0.13) or in prevalence of tumors ≤30 mm in diameter (79% versus 70%,P= 0.30) was observed between the randomized groups.

Conclusion: 

US surveillance, performed every 3 months, detects more small focal lesions than US every 6 months, but does not improve detection of small HCC, probably because of limitations in recall procedures. (Hepatology 2011;)

Copyright © 2011 American Association for the Study of Liver Diseases.

Full Text Access for Subscribers:

AASLD members log in here
AASLD members log in here

Not a Subscriber?

Buy
Request Permissions
Become a Society Member

You can read the full text of this article if you:

Access through Ovid