Clinical trial NCT00848952: Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis
Official title: Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2009-02-23
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate 3 imaging techniques and their associations : MRI, CTscanner and enhanced contrast ultrasound for the diagnosis of small (\< 3 cm) hepatocellular carcinoma for patients with cirrhosis.

Detailed description: With the improvement of cirrhosis complications coverage, hepatocellular carcinoma (HCC) tend to become the main cause of mortality for cirrhotic patients. Currently, the incidence of the HCC increase in occidental country and hid global prognostic remain very bad. The main indication factor for a curative treatment is the size lesion.

Cirrhosis is the main risk factor for HCC occurence. In France, HCC screening has been establish for cirrhotic patients with hepatic ultrasound and alfa-fetoprotein measurement with the aim of detected HCC when the size allows a curative treatment.

When a nodule is discovered during the follow-up, HCC diagnosis is done following the recommendations of European Association for the Study of the Liver (AESL) in 2000, updated by the American Association for the Study of Liver Diseases (AASLD)in 2005. Diagnostic is function of nodule feature on one or two enhanced imaging techniques among CTscanner, MRI and enhanced contrast ultrasound.

This diagnostic strategy raises several questions. First, neither the most efficient dynamic imaging association for nodules from 1 to 2 cm, nor the most efficient imaging examination for nodules from 2 to 3 cm are known. Second, only few studies have been carried out about imaging semiology of the small hepatocellular carcinoma. Thus, the imprecisions of the present recommendations regarding the choice of the best examination technique and the difficulties in the diagnosis of benign or malignant nature for small nodule can lead to a bad management of these patients.

Eligibility criteria: Inclusion Criteria:

* age \> 18 hears
* presence of one or several nodules \< 3 cm
* known or suspected cirrhosis

Exclusion Criteria:

* psychiatric disease
* contraindication to one of the 3 imaging examinations (CTscanner, MRI, enhanced contrast ultrasound
* patient already treated by chemoembolization
* recurrence on the coagulation zone of a nodule already treated by per-cutaneous tumour destruction
* presence of a tumour (\> 3 cm) associated to the nodule
* pregnant woman or breast-feeding woman

Primary outcomes:
measure: Report of proportion of the positives truths and the positive wrong for an examination
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Bordeaux
country: France
facility: Hôpital Saint-André
city: Caen
country: France
facility: Chu
city: Clichy
country: France
facility: hôpital Beaujon
city: Créteil
country: France
facility: hôpital Henri Mondor
city: Dijon
country: France
facility: Hôpital Du Bocage
city: Grenoble
country: France
facility: CHU
city: Lyon
country: France
facility: Hôpital de la croix rousse
city: Lyon
country: France
facility: Hôpital E. Herriot
city: Montpellier
country: France
facility: Hôpital Saint Éloi
city: Nancy
country: France
facility: Hôpital Brabois
city: Nantes
country: France
facility: Hôpital Hôtel Dieu
city: Nice
country: France
facility: hôpital archet II
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Pessac
country: France
facility: Hôpital Haut-Lévèque
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Saint Étienne
country: France
facility: Hôpital Nord
city: Villejuif
country: France
facility: Hôpital Paul Brousse
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References:
citation: Paisant A, Vilgrain V, Riou J, Oberti F, Sutter O, Laurent V, Rodes A, Guiu B, Cassinotto C, Trillaud H, Bricault I, Michalak S, Bruno O, Ronot M, Aube C. Comparison of extracellular and hepatobiliary MR contrast agents for the diagnosis of small HCCs. J Hepatol. 2020 May;72(5):937-945. doi: 10.1016/j.jhep.2019.12.011. Epub 2019 Dec 21.
citation: Aube C, Oberti F, Lonjon J, Pageaux G, Seror O, N'Kontchou G, Rode A, Radenne S, Cassinotto C, Vergniol J, Bricault I, Leroy V, Ronot M, Castera L, Michalak S, Esvan M, Vilgrain V; CHIC Group. EASL and AASLD recommendations for the diagnosis of HCC to the test of daily practice. Liver Int. 2017 Oct;37(10):1515-1525. doi: 10.1111/liv.13429. Epub 2017 Apr 26.