The advent of the first electric driven EUS-guided 17 gauge core needle biopsy - A pilot study on subepithelial lesions.

BACKGROUND AND AIMS: This pilot study aimed to evaluate safety and tissue sampling from subepithelial lesions (SEL) in the upper gastrointestinal tract with a novel electric motor driven endoscopic ultrasonography (EUS)-guided 17-gauge (G) size core needle biopsy (CNB) instrument.

METHODS: An investigator-led prospective open label, performance and safety control study, including seven patients (female n  = 4, median 71 y, range 28-75) with a determined SEL (median size 30 mm, range 17-150 mm) in the upper digestive tract (stomach n  = 6, duodenum n  = 1) were eligible and later followed up 14 days after index procedure. All investigations were completed according to protocol with three FNB 22-G passes with four fanning strokes and two EndoDrill® 17-G passes with three fanning strokes.

RESULTS: Quality of samples as 'visible pieces' (>5 mm): FNB ( n  = 5/7) (fragmented/blood imbibed n  = 1, poor tissue quantity n  = 1) compared with 17-G CNB ( n  = 7/7). Histological result which led to final diagnosis (leiomyoma n  = 2, adenocarcinoma n  = 1, schwannoma n  = 1, neuroendocrine tumour n  = 1, desmoid tumour n  = 1 and gastrointestinal stromal tumour (GIST) n  = 1) could be obtained with the 17-G CNB instrument in all seven patients. FNB technique reached correct diagnosis in six patients. No serious adverse event were recorded.

CONCLUSIONS: By using an electric driven 17-G biopsy device, a true cylinder of core tissue can be obtained in one single puncture from the area of interest reducing the need for a second sampling. The absolute benefit of EUS-guided CNB is that the sample can be handled and histologically prepared in the same manner as standard percutaneous core needle sample, e.g., breast and prostate cancer.