Clinical Trial: Contrast Enhanced Ultrasound For The Evaluation Of Focal Liver Lesions

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Contrast Enhanced Ultrasound for the Evaluation of Focal Liver Lesions - a Multi-center Study on the Usefulness in the Clinical Practice

Brief Summary: The aim of the study is to assess the value of contrast enhanced ultrasound in the evaluation of de novo focal liver lesions in clinical practice, in a prospective multi-center design.

Detailed Summary:

Focal liver lesions (FLL) are quite frequently discovered in daily practice at routine ultrasound and sometimes require the use of extensive investigations for a correct diagnosis, thus increasing the costs and duration of diagnosis. On the other hand, due to screening strategies for patients with liver cirrhosis, FLL are discovered very early in these patients, and they must be evaluated in order to establish a therapeutic strategy (including transplantation, surgical resection or percutaneous echoguided procedures).

Contrast enhanced ultrasound (CEUS) using second generation contrast agents is a relatively new imaging modality that allows the characterization of FLL and allows a positive diagnosis based on the vascular pattern of the lesion. The advantages of this method are the low cost as compared with other imaging modalities and the fact that it can be performed immediately after standard abdominal ultrasound, so approximately 5 minutes after CEUS (the total duration of this investigation) a confident diagnosis can be obtained.

The place of CEUS in the diagnostic algorithm of FLL is not very well established. The European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) issued the first Guidelines regarding the use of CEUS in 2004, revised in 2008, in which the main indications of this method are presented.

The purpose of this study is to establish the value of CEUS in the evaluation of de novo FLL in clinical practice.

The study will include patients discovered with de novo FLL at standard ultrasound in which the ultrasound study is not conclusive for the positive diagnosis (the patients with simple cysts or known FLL under CEUS follow up will be excluded form the study). The standard ultrasound
Sponsor: Societatea Romana de Ultrasonografie in Medicina si Biologie

Current Primary Outcome: evaluation of contrast enhanced ultrasound in the assessment of de novo focal liver lesions [ Time Frame: 12 months evaluation ]

A CEUS examination will be considered conclusive if, following contrast, the FLL had a typical enhancement pattern according to the EFSUMB guidelines, and inconclusive if the enhancement pattern of the lesions was not in concordance with this guide.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Societatea Romana de Ultrasonografie in Medicina si Biologie

Dates:
Date Received: April 2, 2011
Date Started: December 2010
Date Completion: December 2011
Last Updated: April 5, 2011
Last Verified: April 2011