Diagnostic Accuracy of FNA: is Aspiration- Related?

BACKGROUND: EUS-FNA has a central role in the diagnostic algorithm of solid pancreatic masses. Different needle diameters and the use of stylet are not associated with differences in terms of diagnostic yield for malignancy. Preliminary studies showed that using suction (10ml) is associated with a higher sensitivity for cancer diagnosis. We aim to compare EUS-FNA in the same solid pancreatic mass performed with the 22 gauge needle with different aspiration volumes (10, 20, 0ml), looking for adequacy, diagnostic accuracy and complications. METHODS: Prospective clinical study at four referral Centers: ISMETT Palermo; Bellaria-Maggiore, Bologna; Civico-A.R.N.A.S, Palermo; Humanitas-IRCCS, Rozzano. EUS was performed by five experienced echo-endoscopist. The needle system was in all cases the 22 gauge EUS-FNA(Expect). We performed three punctures with a 22 G needle with both volume aspiration 10 and 20 cc and without syringe for each lesion. The sequence (10cc, 20cc, no aspiration) was randomly assigned by sealed envelope system. For each pass tissue samples were smeared into slides for ROSE(Rapid-On-Site-Evaluation); after smearing sample into the slides, the material was fixed in formalin for cyto-histological evaluation. The cyto-pathologist was always blinded as to which aspiration was used for which specimen. After EUS-FNA the patients were monitored for at least six hour to detect immediately post-procedural complication and were followed up during the 30 days post-procedure in order to detect late complications.

Sex

All

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

* diagnosed or suspected solid pancreatic lesions according to imaging (CT-scan or/and MRI);
* no contraindications for FNA (see exclusion criteria).

Exclusion Criteria:

* age \< 18 years;
* cystic pancreatic lesions;
* history of previous gastrectomy;
* patients hemodynamically unstable or with severe coagulopathy (international normalized ratio \[INR\] \> 1.5 or platelet count \< 60.000 cells/cubic millimetre \[cmm3\]);
* patients unable to suspend anticoagulant therapy;
* pregnancy;
* inability to give informed consent;
* refusal to participate to the study.