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A Randomized phase II trial aimed to assess the usefulness of the francine needle in endobronchial ultrasound-guided transbronchial needle aspiration or biopsy

Assessing the usefulness of the francine needle in EBUS-TBNA

12

A: Lancet - Franseen / B: Franseen - Lancet, Each group had 6 participants Age median A 73.5 years B 72.0 years p = 0.639 Sex A 5 male 1 female B 5 male1 femalep= 1.000 Body height median A 163.2cm B 162.6cm p = 0.603 Body weight median A 61.8kg B 55.5kg p = 0.401 Smoking A + 6 - 0 B + 5 - 1 p = 0.296

All 12 cases were completed bronchoscopy. Two specimens in group B were diagnosed as benignity, therefore, the outcome analysis was performed in 10 cases

Bleeding 19, Hypertension 2, Pneumonia 1, Bronchoscope injury 1 Bleeding: (Franseen) Minor 10 (Lancet) Trivial 2, Minor 7 Severe adverse event was not occurred.

Primary outcome: Tissue area Franseen 15.7mm2 Lancet 12.2mm2 p = 0.355 Secondary outcome: Tumor cellularity Franseen 60.0% Lancet 40.0% p = 0.608 Blood contamination rate Franseen 55.0% Lancet 45.0% p = 971 Diagnostic concordance rate 91.7% Success rate of molecular testing Franseen 6/7 (85.7%) Lancet 4/7 (57.1%) Adverse events (Bleeding): 19 cases (Franseen) Minor 10 (Lancet) Trivial 2, Minor 7 Severe adverse event was not occurred. Adverse events (Others): Hypertension 2, Pneumonia 1, Bronchoscope injury 1 Severe adverse event was not occurred.

We conducted a single-center prospective study and assessed the usefulness of Franseen needle dedicated endobronchial ultrasound-guided transbronchial needle aspiration, and found that the Franseen needle tended to show a greater amount of specimen with higher tumor cellularity which may contribute higher success rate of molecular testing.

Aug. 01, 2024

No

None

https://jrct.niph.go.jp/latest-detail/jRCT1032220388

Ikari Jun

Chiba University Hospital

1-8-1 Inohana Chuo-ku Chiba 260-8670, Japan

junikari@chiba-u.jp

Ikari Jun

Chiba University Hospital

1-8-1 Inohana Chuo-ku Chiba 260-8670, Japan

+81-43-222-2576

junikari@chiba-u.jp

Complete

Oct. 18, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

diagnostic purpose

1) Patients with suspected primary lung cancer
2) Patients who are scheduled for endobronchial ultrasound-guided transbronchial needle aspiration or biopsy
3) Patients who are 20 years of age or older
4) Patients who are provided written informed consent

1) Patients who have a history of treatment for lung cancer
2) Patients for whom bronchoscopy is contraindicated
3) Patients who are pregnant, within 28 days postpartum, or lactating
4) Patients who are judged by the investigator to be unsuitable for this study

Both

Lung cancer

Patients are received EBUS-TBNA or TBNB using these devices under randomised:
A: Francine needle - Lancet needle
B: Lancet needle - Francine needle

lung cancer,

Bronchoscopy

D008175

D001999

Tissue area of each lymph node sample

Tumor percentage of each lymph node
Rate of blood contamination in each lymph node
Diagnostic concordance between Francine and Lancet needles
Adverse events
Success rate for biomarker test for each lymph node

+81-43-226-2616

Sept. 30, 2022

none