FEASIBILITY AND EFFICACY OF A NOVEL NEEDLE IN ENDOSCOPIC ULTRASOUNDGUIDED TISSUE SAMPLING FOR PANCREATIC SOLID LESIONS: A PROSPECTIVE RANDOMIZED COMPARATIVE STUDY

Aims Histologic confirmation is crucial in the evaluation of pancreatic solid lesions. Recently, variable needles with different shapes for endoscopic ultrasound guided tissue sampling (EUSTS) have been used, however, most needles are expensive. Therefore, new needle with novel technology and reasonable price is needed. We evaluated the feasibility and efficacy of a newly designed prototype needle for pancreatic solid lesions.

Methods As a prospective randomized trial, a 22gauge needle (22 G, ClearTip, FINEMEDIX, Daegu, Korea) with side hole of both reversed bevel (test needle) was compared to three commercially available 22 G biopsy needles (control needles) in patients who undergoing EUSTS of pancreatic solid lesions. First two passes of EUSTS were accomplished in a random order between test and control needles. The procured specimens were prepared and compared specimen adequacy and diagnostic accuracy among needles. Additional two passes were performed using the control needle for histologic diagnosis. Two blinded pathologists evaluated the specimens based on predetermined diagnostic criteria for cytology and histology.

Results Between February and June 2018, 24 patients (median 63.5 years, 14 males) with pancreatic solid lesions were enrolled. Mean size of mass lesion was 32.4 mm ± 2.8. Among them, one patient had no final diagnosis due to inadequate specimen. Technical failure occurred in one case of test needle. Final diagnosis was pancreatic ductal adenocarcinoma in 19, neuroendocrine tumor in 1, metastasis in 1, and chronic pancreatitis in 2. There was no significant difference between test and control needles in terms of specimen adequacy (95.5% vs. 95.7%) and diagnostic accuracy (69.6% vs. 82.6%) (p value = 1.000 and 0.491, respectively). There were no adverse events in all patients.

Conclusions The new prototype needle is feasible and efficient for EUSTS in pancreatic solid lesions. However, further study including large volume and for other lesions is needed to validate these results.