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

Background 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 $ OncoGuide^{™} $ NCC Oncopanel System (NOP) analysis suitability criteria. Methods In 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 $ mm^{2} $. Results Thirty-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. Conclusions 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..

Medienart:

E-Artikel

Erscheinungsjahr:

2022

Erschienen:

2022

Enthalten in:

Zur Gesamtaufnahme - volume:57

Enthalten in:

Journal of gastroenterology - 57(2022), 12 vom: 03. Okt., Seite 990-998

Sprache:

Englisch

Beteiligte Personen:

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

Links:

Volltext [lizenzpflichtig]

BKL:

44.87$jGastroenterologie

Themen:

Comprehensive genomic profiling
Endoscopic ultrasound-guided fine-needle biopsy
Endoscopic ultrasound-guided tissue acquisition
Next-generation sequencing
Pancreatic cancer

RVK:

RVK Klassifikation

Anmerkungen:

© Japanese Society of Gastroenterology 2022. Springer Nature or its licensor holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

doi:

10.1007/s00535-022-01926-z

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

OLC2132718555

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