臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 18, 2022
Last modified on	April. 03, 2024
Trial ID	jRCT1032220388

Scientific Title	A Randomized phase II trial aimed to assess the usefulness of the francine needle in endobronchial ultrasound-guided transbronchial needle aspiration or biopsy
Public Title	Assessing the usefulness of the francine needle in EBUS-TBNA

Contact for Scientific Queries	Name	Ikari Jun
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana Chuo-ku Chiba 260-8670, Japan
	Telephone	+81-43-222-2576
	E-mail	junikari@chiba-u.jp
Contact for Public Queries	Name	Ikari Jun
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana Chuo-ku Chiba 260-8670, Japan
	Telephone	+81-43-222-2576
	E-mail	junikari@chiba-u.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 18, 2022
Actual date of first enrollment
Target sample size		12
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	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
	Exclusion Criteria	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
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Lung cancer
Intervention(s)		Patients are received EBUS-TBNA or TBNB using these devices under randomised: A: Francine needle - Lancet needle B: Lancet needle - Francine needle
Health Condition(s) Keyword		lung cancer,
Intervention(s) Keyword		Bronchoscopy
Health Condition(s) Code		D008175
Intervention(s) Code		D001999
Primary Outcome(s)		Tissue area of each lymph node sample
Secondary Outcome(s)		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

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Clinical Research Initiation - Fund of Chiba University Hospital
Secondary Sponsor	Not applicable

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1 Inohana, Chuo-ku, Chiba City, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	April. 03, 2024	(this page)	Changes
3	April. 02, 2024	Detail	Changes
2	April. 10, 2023	Detail	Changes
1	Oct. 18, 2022	Detail

List of change history