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

Autor: Yuya Hisada, Susumu Hijioka, Go Ikeda, Kosuke Maehara, Taiki Hashimoto, Hidetoshi Kitamura, Shota Harai, Motohiro Yoshinari, Yuki Kawasaki, Yumi Murashima, Takehiko Koga, Kotaro Takeshita, Yuta Maruki, Akihiro Ohba, Yoshikuni Nagashio, Shunsuke Kondo, Chigusa Morizane, Hideki Ueno, Yutaka Saito, Yasushi Yatabe, Takuji Okusaka
Rok vydání: 2022
Předmět:
Zdroj: Journal of Gastroenterology. 57:990-998
ISSN: 1435-5922
0944-1174
Popis: There 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 OncoGuideIn 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 mmThirty-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.The 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.
Databáze: OpenAIRE
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