Evidence map›Paper›PMID 31531819›Full record

Trial reportDigestive diseases and sciences2020

Endoscopic Ultrasound-Guided Fine Needle Biopsy Using 22-Gauge Franseen Needle for the Histological Diagnosis of Solid Lesions: A Multicenter Prospective Pilot Study.

Naoki Mita, Takuji Iwashita, Shinya Uemura, Yuhei Iwasa, Katsuhisa Toda, Tsuyoshi Mukai, Tatsuhiko Miyazaki, Ichiro Yasuda, Masahito Shimizu

Abstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Naoki MitaFirst Department of Internal Medicine, Gifu University Hospital, 1-1 Yanagido, Gifu, 501-1194, Japan.
Takuji IwashitaFirst Department of Internal Medicine, Gifu University Hospital, 1-1 Yanagido, Gifu, 501-1194, Japan. takuji@w7.dion.ne.jp.ORCID 0000-0003-4978-1787
Shinya UemuraFirst Department of Internal Medicine, Gifu University Hospital, 1-1 Yanagido, Gifu, 501-1194, Japan.
Yuhei IwasaFirst Department of Internal Medicine, Gifu University Hospital, 1-1 Yanagido, Gifu, 501-1194, Japan.
Katsuhisa TodaDepartment of Gastroenterology, Chuno Kosei Hospital, Gifu, Japan.
Tsuyoshi MukaiDepartment of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan.
Tatsuhiko MiyazakiDepartment of Pathology, Gifu University Hospital, Gifu, Japan.
Ichiro YasudaThird Department of Internal Medicine, University of Toyama Hospital, Toyama, Japan.
Masahito ShimizuFirst Department of Internal Medicine, Gifu University Hospital, 1-1 Yanagido, Gifu, 501-1194, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecently, a novel 22-gauge needle with three symmetric needle points and crown-shaped cutting heels, known as a Franseen needle, has been developed for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB).

aimTo assess the histological material acquisition rate and histological diagnostic capability of the 22-gauge Franseen needle (AC22) during EUS-FNB for solid lesions.

methodsThis study was designed as an open-label, multicenter, prospective, single-arm pilot study of EUS-FNB using AC22 for the diagnosis of solid lesions. Three passes of FNB using AC22 were performed for all lesions. The primary endpoints were the histological material acquisition rate and histological diagnostic capability. The secondary endpoints were the technical success rate, quality of histological samples, number of passes for diagnosis, and safety.

resultsBetween September 2017 and May 2018, 75 patients were enrolled. The final diagnoses were malignancy in 65 and benign in 10. Three passes of FNB were technically successful in all patients. The sensitivity, specificity, and accuracy for the malignancy of histological analyses were 92.3% (60/65), 100% (10/10), and 93.3% (70/75), respectively, for the first pass and 95.4% (62/65), 100% (10/10), and 96% (72/75), respectively, for combined three passes. The diagnostic yield plateaued after the second pass. Sufficient tissue samples for histological interpretation were obtained in 96% (72/75) and 100% (75/75) patients for the single pass and combined three passes, respectively. Two patients (2.7%) developed mild pancreatitis as an adverse event.

conclusionEUS-FNB using AC22 showed high histological diagnostic capability with the high first pass yield. CLINICAL TRIALS REGISTRY: UMIN Clinical Trials Registry (UMIN ID: UMIN000036641).

Indexed as

NeedlesAdultAgedAged, 80 and overEndoscopic Ultrasound-Guided Fine Needle AspirationEndosonographyFemaleHumansImage-Guided BiopsyMaleMiddle AgedNeoplasmsPilot ProjectsProspective StudiesEndoscopic ultrasound-guided fine needle aspirationEndoscopic ultrasound-guided fine needle biopsyFranseenHistologyTissue acquisition

Identifiers

PMID31531819

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.