A RETROSPECTIVE ASSESSMENT OF A NEW FRANSEEN-TIP NEEDLE’S DIAGNOSTIC PERFORMANCE AND ITS COMPARISON WITH STANDARD FNA NEEDLES AND WITH PROCORE 20G NEEDLE

Aims New biopsy needles for EUS-guided tissue acquisition are gradually replacing traditional FNA needles in clinical practice. We aimed to assess the diagnostic performance and histological diagnostic yield of the new Franseen-tip needle comparing it with Echo-tip FNA needles (20 and 25G) and with ProCore-tip FNB needles (20G).

Methods 95 consecutive cases of pancreatic and extrapancreatic EUS-FNB performed with a Franseen needle were investigated retrospectively and compared with 149 cases of EUS-FNA with FNA standard needle and with 46 cases of EUS-FNB with ProCore 20G needle in the same period, without ROSE. Final diagnoses were based on surgical pathology or on a minimum six-month clinical follow-up.

Results Diagnostic adequacy rate was 100% for Franseen needle, 94% for FNA needles and 86% for ProCore needle (p value< 0,05). Sensitivity, specificity, diagnostic accuracy, PPV and NPV on pancreatic lesions were respectively 90,9%, 100%, 92,2%, 100%, 64,3% for Acquire, 92,6%, 91,7%, 92,5%, 98,4 e 68,7% for FNA needles and 90,3%, 100%, 90,6%, 100% and 25% for ProCore needle. Mean number of passes was respectively 3,5±1,3, 3,9±1,4 and 1,8±0,8 (p value< 0,05). There was no significant difference in extrapancreatic diagnostic yield (86,7% vs 81,4%) nor in adverse event rate (4% vs 2%) between Acquire and FNA needles. Histological evaluation, available for 33 Franseen’s and for 20 FNA needle’s specimens, showed significant superiority of Franseen needles in tissue core’s length (1534,2±929 vs 669,1±593 micron) and in histological adequacy’s rate (87,9% vs 55,0%).

Conclusions Franseen needle’s clinical performance is similar to FNA needles when histological analysis is not required, but the adequacy rate (in absence of ROSE) and the capability to acquire histological core tissue specimens are significantly superior. Franseen needle required fewer passes than FNA needles and more passes than ProCore needles. Adverse events were mild and very rare.