Feasibility of a 20-gauge ProCore needle in EUS-guided subepithelial tumor sampling: a prospective multicenter study

Do Hoon Kim, Gwang Ha Kim, Chang Min Cho, Chang Hwan Park, Soo-Young Na, Tae Hyeon Kim, Yu Kyung Cho, Ji Hyun Kim, Dong-Wan Seo, Korean EUS Study Group, Do Hoon Kim, Gwang Ha Kim, Chang Min Cho, Chang Hwan Park, Soo-Young Na, Tae Hyeon Kim, Yu Kyung Cho, Ji Hyun Kim, Dong-Wan Seo, Korean EUS Study Group

Abstract

Background: Endoscopic ultrasonography-guided fine-needle biopsy (EUS-FNB) may facilitate tissue acquisition for a definitive diagnosis of gastrointestinal subepithelial tumors (SETs). This study aimed to determine the diagnostic yield of EUS-FNB using a novel 20-gauge ProCore needle with a coiled sheath in tissue sampling of gastrointestinal SETs.

Methods: Between July 2016 and February 2017, 39 patients with gastrointestinal SETs were prospectively recruited from six university hospitals in Korea. Hypoechoic SETs ≥2 cm in size and originating from the submucosal and/or muscularis propria layer under EUS were eligible. This study was registered on ClinicalTrials.gov (NCT02884154).

Results: A total of 36 patients were included in the final analyses. EUS-FNB was diagnostic in 88.9% of SETs. Tissue adequacy was judged as optimal in 97.2% of FNB specimens according to on-site visual evaluation by endosonographers, and in 88.9% of specimens according to pathologists. A macroscopically optimal core sample was obtained with two needle passes in 94.4% of cases. Technical failure rate was encountered in two cases (5.6%) after two needle passes. There were two cases (5.6%) of bleeding, which was managed endoscopically.

Conclusions: EUS-FNB using a 20-gauge ProCore needle is a technically feasible and effective modality for histopathologic diagnosis of gastrointestinal SETs, providing adequate core samples with fewer needle passes; ClinicalTrials.gov number, NCT02884154.

Keywords: Biopsy; Endoscopic ultrasonography; Gastrointestinal tract; Subepithelial tumor.

Conflict of interest statement

Ethics approval and consent to participate

All enrolled patients provided written informed consent for their participation in the study. The study protocol was approved by the institutional review board of each hospital (Asan Medical Center, Pusan National University Hospital, Kyungpook National University School of Medicine, Chonnam National University Medical school, Jeju National University School of Medicine, Wonkwang University School of Medicine, Seoul St. Mary’s Hospital, and Inje University Pusan Paik Hospital) and was conducted in accordance with the Declaration of Helsinki and its amendments, and the Good Clinical Practice guidelines. This study was also registered on Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Macroscopic and microscopic specimens from endoscopic ultrasound-guided fine-needle biopsy with a 20-gauge ProCore needle. a Gross findings of the endoscopic ultrasonography-guided fine needle biopsy specimen. b Hematoxylin and eosin stain from the core biopsy of a gastrointestinal stromal tumor (× 40)
Fig. 2
Fig. 2
Flowchart of the study
Fig. 3
Fig. 3
Tissue adequacy according to the needle passes

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