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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034705
Receipt No. R000039570
Official scientific title of the study An observational study for comparison of diagnostic yield, maneuverability and safety between 22-gauge and 25-gauge needles for endobronchial ultrasound-guided transbronchial needle aspiration.
Date of disclosure of the study information 2018/11/01
Last modified on 2018/10/30

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Basic information
Official scientific title of the study An observational study for comparison of diagnostic yield, maneuverability and safety between 22-gauge and 25-gauge needles for endobronchial ultrasound-guided transbronchial needle aspiration.
Title of the study (Brief title) An observational study for comparison of diagnostic yield, maneuverability and safety between 22-gauge and 25-gauge needles for endobronchial ultrasound-guided transbronchial needle aspiration.
Region
Japan

Condition
Condition malignant and benign mediastinal hilar lymphadenopathy.
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To comparison of diagnostic yield, maneuverability and safety between 22-gauge and 25-gauge needles for endobronchial ultrasound-guided transbronchial needle aspiration.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of the diagnostic yield between 22-gauge and 25-gauge needles for endobronchial ultrasound-guided transbronchial needle aspiration.
Key secondary outcomes Comparison of the diagnostic yield based on malignant and benign regions, histological diagnostic yield and cytological diagnostic yield, quantity of histological core tissue, maneuverability, safety

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 with hilar and mediastinal lymphadenopathy.
20 years old and above
Key exclusion criteria Patients who are considered as inappropriate by physician.
Rebiopsy to detect resistance mutation
Target sample size 60

Research contact person
Name of lead principal investigator Tadashi Sakaguchi
Organization Matsusaka Municipal Hospital
Division name Department of respiratory medicine
Address 1550, Tonomachi, Matsusaka, Mie, 515-0073, Japan
TEL 0598-23-1515
Email mchsakaguchi@city-hosp.matsusaka.mie.jp

Public contact
Name of contact person Tadashi Sakaguchi
Organization Matsusaka Municipal Hospital
Division name Department of respiratory medicine
Address 1550, Tonomachi, Matsusaka, Mie, 515-0073, Japan
TEL 0598-23-1515
Homepage URL
Email mchsakaguchi@city-hosp.matsusaka.mie.jp

Sponsor
Institute Matsusaka Municipal Hospital
Institute
Department

Funding Source
Organization Matsusaka Municipal Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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 11 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 25 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information The trial will start soon.

Management information
Registered date
2018 Year 10 Month 30 Day
Last modified on
2018 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039570

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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