Conventional Versus Elastography Targeted Endoscopic Ultrasound Fine Needle Aspiration of Solid Pancreatic Lesions

Diagnostic assessment of solid pancreatic lesions may represent a real challenge in the clinical practice, even with the aid of tissue sampling by means of endoscopic ultrasound (EUS) fine needle aspiration (FNA).

Aim of this multicenter randomized controlled trial (RCT) is to establish the diagnostic accuracy, sensitivity, and specificity of real time elastography (RTE)-guided EUS-FNA as compared to conventional EUS-FNA in a series of patients with solid pancreatic masses.

Eligible will be patients with solid pancreatic masses detected at abdominal imaging (ultrasound, CT-scan or MRI).

In the treatment arm, RTE assessment of pancreatic masses will be performed using a last generation ultrasound machine, and all suspicious areas at elastography (i.e. those appearing in dark blue color as a consequence of higher cellularity of tumoral tissue) will be recorded and stored in our database. A 25 G needle will be then inserted into the most suspicious part ("dark blue") of the lesion and immediately after the procedure the stylet will be removed. At the end of the procedure, the needle will be retracted and the samples, after being checked for adequacy by an on-site cytotechnician, will be prepared for cytological examination.

Primary endpoint will be diagnostic yield of the procedure. Secondary endpoints the diagnostic sensitivity, specificity, number of passes needed to achieve an adequate sample and safety It will be planned to enroll 280 patients (140 per arms) within 1 year. A minimum follow up of 12 months from the last patient unsuitable to surgery will be required.