Abstract
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.
Acknowledgments
We would like to sincerely thank Dr. Charles Walther, the inventor of EndoDrill® and for the technical support from the team at BiBBinstruments AB. We would like to thank Lena Lyons for the valuable and descriptive illustrations.
Authors contributions
Fredrik Swahn, Robert Glavas, Malin Wickbom contributed to the design of the work. Robert Glavas and Malin Wickbom involved in data collection. Fredrik Swahn and Lucin Hultin contributed to data analysis. Fredrik Swahn and Malin Wickbom contributed to drafting the article. Fredrik Swahn, Robert Glavas, Lucin Hultin and Malin Wickbom involved in critical revision of the article. Fredrik Swahn, Malin Wickbom, Robert Glavas and Lucin Hultin provided final approval of the version to be published.
Disclosure statement
Fredrik Swahn has clinical consultations with Boston Scientific Nordic AB Sweden and has previously received honoraria for lectures and clinical consultations from COOK Medical Sweden and AMBU Denmark.
Robert Glavas has educational collaborations with Olympus Sverige AB.
Lucin Hultin have declared no conflict of interest.
Malin Wickbom have declared no conflict of interest.