Journal Article

Proportion of unresectable pancreatic cancer specimens obtained by endoscopic ultrasound-guided tissue acquisition meeting the OncoGuide™ NCC Oncopanel System analysis suitability criteria: a single-arm, phase II clinical trial

Hisada, Yuya, Nagashio, Yoshikuni, Saito, Yutaka, Kitamura, Hidetoshi, Morizane, Chigusa, Kawasaki, Yuki, Koga, Takehiko, Maruki, Yuta, Hashimoto, Taiki, Yatabe, Yasushi, Maehara, Kosuke, Yoshinari, Motohiro, Takeshita, Kotaro, Ohba, Akihiro, Harai, Shota, Ikeda, Go, Murashima, Yumi, Ueno, Hideki, Hijioka, Susumu, Kondo, Shunsuke, Okusaka, Takuji

2022

Overview

BackgroundThere are limited studies on the results of comprehensive genomic profiling testing for pancreatic cancer tissue specimens by endoscopic ultrasound-guided tissue acquisition (EUS-TA). This study aimed to evaluate the proportion of specimens obtained by EUS-TA using a 19-gauge (G) fine-needle biopsy (FNB) needle for unresectable pancreatic cancer (UR-PC) that met the OncoGuide™ NCC Oncopanel System (NOP) analysis suitability criteria.MethodsIn this single-arm, prospective, phase II study, EUS-TA was performed using a 19G FNB biopsy needle in patients with suspected UR-PC based on a contrast-enhanced computed tomography scan. The primary endpoint was the proportion of patients who met the NOP analysis suitability criteria, with a threshold, expected value, α-error, and power of 40%, 70%, 0.025, and 0.9, respectively, and the planned number of enrolled patients was 33. The NOP analysis suitability criteria were defined as tumor cell content ≥ 20% and tissue size ≥ 4 mm2.ResultsThirty-three patients were enrolled. The procedural success rate was 100%, and the cytodiagnosis of class V was observed in all patients. The proportion of patients meeting the NOP analysis suitability criteria was 63.6% (95% CI 47.22–80.05), which satisfied the predefined criteria to be considered valid. Adverse events occurred in 9.0% of the patients.ConclusionsThe proportion of patients with UR-PC who met the NOP analysis suitability criteria for EUS-TA using a 19G FNB needle was effective for achieving the primary endpoint, making it a valid test method. Adverse events occurred at a higher rate than that previously reported.

• Publisher: Springer Nature B.V
• Subject: Adverse events / Biopsy / Computed tomography / Endoscopy / Pancreatic cancer / Ultrasonic imaging / Ultrasound