Study Protocol for a Prospective Self-Controlled Trial on Success in Meeting Comprehensive Genomic Profiling Analysis Criteria for Specimens Obtained by Endoscopic Ultrasound-Guided Tissue Acquisition Using a 19G Needle from Primary and Metastatic Lesions

Kotaro Takeshita; Susumu Hijioka; Yoshikuni Nagashio; Hidenobu Hara; Daiki Agarie; Yuki Kawasaki; Tetsuro Takasaki; Shin Yagi; Yuya Hagiwara; Kohei Okamoto; Daiki Yamashige; Soma Fukuda; Masaru Kuwada; Yasuhiro Komori; Mao Okada; Yuta Maruki; Chigusa Morizane; Hideki Ueno; Yasushi Yatabe; Takuji Okusaka

doi:10.20944/preprints202406.1410.v1

Preprint Article Version 1 This version is not peer-reviewed

Version 1 : Received: 19 June 2024 / Approved: 20 June 2024 / Online: 20 June 2024 (13:14:56 CEST)

EUS–TA in unresectable pancreatic cancer requires not only a tissue diagnosis but also tissue collection in anticipation of comprehensive genomic profiling. However, the optimal puncture target remains controversial. Therefore, the Primary and Metastatic Lesions in Pancreatic Cancer (PRIMATE) study was designed to clarify the optimal target by comparing the success rates for meeting OncoGuide NCC Oncopanel (NOP) analysis criteria on pre-check primary and metastatic lesion specimens obtained during the same EUS–TA session in patients with invasive pancreatic ductal adenocarcinoma. In this ongoing prospective study, two specimens, each from primary and metastatic lesions, are obtained by EUS–TA (typically using a 19G fine-needle biopsy needle) in patients with invasive pancreatic ductal adenocarcinoma. The primary endpoint is the proportion of EUS–TA specimens that meet NOP analysis criteria during pre-check (i.e., tumor cellularity ≥ 20% and tissue area ≥ 4 mm2), which are then compared between primary and metastatic lesions. This study has been approved by the National Cancer Center Institutional Review Board (Research No. 2022-168). The results of this study will be reported at an international conference and published in an international peer-reviewed journal. The trial registration number is UMIN 000048966.

endoscopic ultrasound-guided tissue acquisition; comprehensive genomic profiling; pancreatic cancer; metastatic lesion; fine-needle biopsy

Medicine and Pharmacology, Gastroenterology and Hepatology

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Study Protocol for a Prospective Self-Controlled Trial on Success in Meeting Comprehensive Genomic Profiling Analysis Criteria for Specimens Obtained by Endoscopic Ultrasound-Guided Tissue Acquisition Using a 19G Needle from Primary and Metastatic Lesions

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