UMIN-CTR Clinical Trial

Basic information
Public title	Identification of factor influencing detectability on endobronchial ultrasound-guided transbronchial needle aspiration (cross-sectional study)
Acronym	Identification of factor influencing detectability on endobronchial ultrasound-guided transbronchial needle aspiration
Scientific Title	Identification of factor influencing detectability on endobronchial ultrasound-guided transbronchial needle aspiration (cross-sectional study)
Scientific Title:Acronym	Identification of factor influencing detectability on endobronchial ultrasound-guided transbronchial needle aspiration
Region	Japan

Condition
Condition	Lung cancer, Sarcoidosis
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the appropriate number of needle stroke movements per puncture in EBUS-TBNA.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The detectability of lesions in three groups according to the number of the stroke movements: the low-number group (20 times), the moderate-number group (25 times), and the high-number group (30 times).
Key secondary outcomes	1)Correlation between the detectability and size of lesions 2)The detectability of lesions of lung cancer and sarcoidosis. 3)The detectability of non-necrotizing granulomas in TBLB and EBUS-TBNA. 4)The rate of contraflow of blood in the EBUS-TBNA procedures

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	all patients with histologically proven lung cancer or sarcoidosis who had previously undergone EBUS-TBNA at the University of Miyazaki Hospital between April 2014 and July 2016.
Key exclusion criteria	the patients rejected to use the data for the clinical study
Target sample size	128

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hironobu Tsubouchi
Organization	Faculty of Medicine, University of Miyazaki
Division name	Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address	Kihara 5200, Kiyotake, Miyazaki
TEL	0985-85-2965
Email	hironobu_tsubouchi@med.miyazaki-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hironobu Tsubouchi
Organization	Faculty of Medicine, University of Miyazaki
Division name	Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address	Kihara 5200, Kiyotake, Miyazaki
TEL	0985-85-2965
Homepage URL
Email	hironobu_tsubouchi@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki
Institute
Department

Funding Source
Organization	None
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
Address
Tel
Email

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	2018 Year 01 Month 22 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	128
Results	We reviewed the EBUS-TBNA data of sarcoidosis (n = 29) and lung cancer (n = 99) patients. Using the data of their 43 sarcoidosis and 139 lung cancer lymph nodes, we evaluated the correlation between the detectability of granulomatous lesions or malignant lesions and the number of needle-stroke movements. The number of needle stroke may influence the detectability of granulomatous lesions in sarcoidosis due to blood contamination caused by the contraflow of blood.
Results date posted	2019 Year 10 Month 25 Day
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	Completed
Date of protocol fixation	2016 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date	2016 Year 09 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study Design: Cross-sectional study. Setting & Participants: Among subjects who had undergone EBUS-TBNA between April 2014 and July 2016.

Management information
Registered date	2017 Year 05 Month 17 Day
Last modified on	2019 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031367

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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