THE USE OF A NEW CORE NEEDLE IN THE ENDOSCOPIC ULTRASOUND ASSISTED TISSUE SAMPLING FOR PANCREATIC SOLID MASSES: A MULTICENTRE PROSPECTIVE STUDY

Aims:

Endoscopic ultrasound-guided biopsy (EUS-biopsy) is safe and effective technique for obtaining samples from pancreatic masses. The aim of the present study was to evaluate the presence of a histological sample using 25G SharkCore Needles (Medtronic, Dublin, Ireland).

Methods:

This was an observational multicenter prospective non-randomized clinical trial (NCT02946840). All consecutive patients referred for EUS of solid pancreatic masses underwent EUS-biopsy with a 25G SharkCore needle. Three passes were performed in every mass. A macroscopic on-site quality evaluation (MOSE) of the specimen was done by the endoscopist. If a “worm-like” material was observed at groß visual assessment, it was placed into formalin. If drop-like material was obtained, it was smeared between 2 glass slides. The primary outcome was the procurement rates of histologic core. Pathologists defined core all histological samples with architecturally intact histology, measuring at least 5 mm in greatest axis. The final diagnosis was based on surgical resection, and clinical/radiological follow up. The secondary outcomes were diagnostic accuracy and procedure-related adverse events.

Results:

Study population included 100 patients, enrolled in 3 centres, between Aug 2016 and May 2017, with a mean age of 65.0 years (SD 13.2, range 22 – 88) and 56% female gender. The mean size of the lesions was 28.5 mm (SD 11.7). Three needle passes were performed in

At MOSE, endoscopists described presence of “worm-like” material in 241 samples over 294 (82.0%).

Four cases of mild self-limited bleeding were observed (4%) and other two complications were described: one retroperitoneal hematoma and one GI wall hematoma. The pathologists described the presence of a core in 103 samples (43.3%). A final diagnosis was reached in 94 patients (94%): 64 pancreatic adenocarcinoma, 19 NET, 7 chronic pancreatitis, 2 pancreatic metastasis from other organs, 2 others.

Conclusions:

The new biopsy needle showeda good overall adequacy and a good rate of histological specimens during EUS-biopsy of pancreatic masses, with a minimum number of passes and no major complications.