Published online Oct 7, 2020. doi: 10.3748/wjg.v26.i37.5693
Peer-review started: July 29, 2020
First decision: August 8, 2020
Revised: August 21, 2020
Accepted: September 15, 2020
Article in press: September 15, 2020
Published online: October 7, 2020
The introduction of fine needle biopsies (FNB) to clinical practice presents a changing trend towards histology in the endoscopic ultrasound-guided tissue acquisition (EUS-TA).
To evaluate the clinical performance of a new FNB needle, the 22-gauge (22G) Franseen needle, when sampling pancreatic solid lesions.
Consecutive patients with an indication for EUS-TA for the assessment of pancreatic solid lesions were included in this prospective, single-center, single-arm trial. Each patient underwent a puncture of the lesion two times using the 22G Franseen needle and the obtained samples were directly placed into formalin for histological analysis. The primary study endpoint was the rate of high-quality obtained specimen. Secondary endpoints included the length and diameter of the core specimen, the diagnostic accuracy and the complication rate.
From June 2017 to December 2018, forty patients with pancreatic solid lesions (22 females; mean age 67.2 years) were enrolled. Tissue acquisition was achieved in all cases. High-quality histology, rated with Payne score 3, was obtained in 37/40 cases (92.5%) after two needle passes. The mean size of the acquired histological core tissue was 1.54 mm × 0.39 mm. The diagnostic accuracy for the correct diagnosis was 85% (34/40). Only one adverse event was occurred, consisting of a self-limiting bleeding in the puncture site.
The 22G Franseen needle achieved according to our standardized protocol a high rate of histological core procurement, and a high diagnostic accuracy, with one minor adverse event reported.
Core Tip: Endoscopic ultrasound-guided tissue acquisition (EUS-TA) has been established in the evaluation of pancreatic masses and recently developed fine needle biopsy (FNB) needles improve the diagnostic yield of EUS-TA providing tissue blocks for performing immunohistochemistry and flow cytometry. We prospectively evaluated the Franseen needle when sampling pancreatic solid lesions. EUS-FNB with the 22-gauge Franseen needle achieved a high rate of histological core procurement and high diagnostic accuracy after only two passes and flushing out the acquired samples directly into formalin, without a rapid on-site evaluation by a cytopathologist or macroscopic on-site evaluation by the endoscopist.