Ultrasonographic surveillance of hepatocellular carcinoma... : Hepatology (original) (raw)

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)

1_AP-HP, Hôpital Jean Verdier, Service d'Hépato-gastroentérologie, Bondy, F-93140, France_

2_Université Paris 13 Paris-Nord, UFR SMBH, Bobigny, F-93000, France_

3_AP-HP, Hôpital Saint-Louis, DBIM, Paris, F-75010, France_

4_Inserm, Université Paris Diderot, UMR 717, Paris, F-75010, France_

5_AP-HP, Hôpital Beaujon, Service d'Hépatologie, Clichy, F-92110, France_

6_Université Paris 7 Denis-Diderot, Faculté de Médecine, Paris, F-75018, France_

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

8_AP-HP, Hôpital Cochin, Service d'Hépatologie, Paris, F-75014, France_

9_Université Paris 5, Paris, F-75014, France_

10_AP-HP, Hôpital Avicenne, Unité d'Hépatologie, Bobigny, F-93000, France_

11_AP-HP, Hôpital Henri Mondor, Service d'Hépatologie, Créteil, F-94000, France_

12_Université Paris-Est Créteil, Créteil, F-94000, France_

13_Service d'Hépato-gastroentérologie, Hôpital Foch, Suresnes, France_

14_Service d'Hépato-gastroentérologie, CHU, Angers, France_

15_Service d'Hépato-gastroentérologie, CHU, Caen, France_

16_Service d'Hépato-gastroentérologie, CHU, Université de Toulouse, INSERM U858, Toulouse, France_

17_Service d'Hépato-gastroentérologie, CHU, Lille, France_

18_Service d'Hépato-gastroentérologie, CHU de Nancy, Vandœuvre, France_

19_AP-HP, Hôpital Beaujon, Service de Radiologie, Clichy, F-92110, France_

20_INSERM 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.

c_fax: 33-1-48-02-62-02_

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;)