PERFORMANCE OF EUS-FNA WITH A NEW FLEXIBLE 19 G NEEDLE FOR DIAGNOSING SOLID LESIONS OF THE HEAD AND UNCINATE PROCESS OF THE PANCREAS. PROSPECTIVE, MULTICENTER STUDY

Aims Large bore needles aim to overcome the frequent unavailability of the rapid on site evaluation (ROSE) of the EUS-FNA samples. However, its rigidity causes a high failure of the technique in lesions of the head and uncinated process of the pancreas.

Objective To evaluate the technical and diagnostic success of a 19 G new nitinol needle with a multilayer coil sheath (EZ Shot 3 plus, Olympus) in solid lesions of the head and uncinated process of the pancreas.

Methods Prospective and multicenter study. A maximum of 5 passes with the study needle were allowed.

Results We included 75 patients (51% males) with lesions in the head (n = 68; 91%) and uncinated process (n = 7; 9%) (mean size: 33 ± 12 mm; number of passes: 1.8 ± 0.9). The technical success rate was 71/75 (94.7%) and the diagnosis success was 89.3% (67/75) and 94.4% (67/71) in a ITT and PP analysis, respectively. Final diagnoses were: adenocarcinoma (n = 59), TNE (n = 5), metastasis (n = 2), lymphoma (n = 2) and others (n = 7). In the 8 cases without diagnosis with the needle, it was obtained with an alternative needle of 22 or 25 G (n = 4), FNA of another lesion (n = 3), follow up (n = 1). A histological sample was obtained in 64/71 (90%) and immunohistochemistry was successfully performed in 11/13 lesions in which it was required. ROSE was performed in 40 (53%) cases with no differences between ROSE and non-ROSE groups regarding diagnostic success (87.5% vs 91%, p = 0.582) or diagnoses at the first pass (70% vs 81%, p = 0.289). The number of passes was lower in the ROSE group (1.4 ± 0.9 vs 2.2 ± 0.7, p = 0.000).

Conclusions The EZ Shot 3 plus has a high technical and diagnostic success in solid masses in the head and uncinated process of the pancreas. This new needle may be a good choice when on-site evaluation is not possible.