UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of utility of biopsy needle in EBUS-TBNA
Acronym	Comparison of utility of biopsy needle in EBUS-TBNA
Scientific Title	Comparison of utility of biopsy needle in EBUS-TBNA
Scientific Title:Acronym	Comparison of utility of biopsy needle in EBUS-TBNA
Region	Japan

Condition
Condition	Lung cancer, mediastinal/hilar lymph node swelling
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clear the diagnostic difference of the biopsy between conventional 22G needle and newly developed 25G needles (produced by Boston scientific, or Cook).
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Concordance of pathological findings
Key secondary outcomes	Rate of obtaining histological core, pathological area, quality of cytological samples (lymphocyte/bleeding score), rapid on site evaluation, diagnostic rate in each station

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who received EBUS-TBNA.
Key exclusion criteria	Patients judged inappropriate by the attending.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Ichiro Middle name Last name Yoshino
Organization	Chiba University Graduate School of Medicine
Division name	General Thoracic Surgery
Zip code	260-8670
Address	1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL	043-222-7171
Email	iyoshino@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Yuichi Middle name Last name Sakairi
Organization	Chiba University Graduate School of Medicine
Division name	General Thoracic Surgery
Zip code	260-8670
Address	1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL	043-222-7171
Homepage URL
Email	y_sakairi1@chiba-u.jp

Sponsor
Institute	Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Chiba University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Review Committee, Chiba University Graduate School of Medicine
Address	1-8-1, Inohana, Chuo-ku, Chiba, Japan
Tel	043-222-7171
Email	igaku-rinri@office.chiba-u.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	63
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 07 Month 13 Day
Date of IRB	2020 Year 08 Month 03 Day
Anticipated trial start date	2017 Year 09 Month 05 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Clinical information related to the diagnosis of biopsy is collected by EBUS-TBNA using 25G needle manufactured by Boston Scientific Co., Ltd, and 25G ProCore needle manufactured by Cook Co., Ltd. Biopsy results performed by 22G conventional needle for same lymph node, is a control of this study. Epidemiological verification is conducted by prospectively registered database, in terms of mediastinal/hilar nodal diagnosis due to difference in puncture needle.

Management information
Registered date	2017 Year 09 Month 05 Day
Last modified on	2020 Year 09 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031819