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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036680
Receipt No. R000041787
Scientific Title The prospective randomized controlled trial of endbronchial ultrasound-guided transbronchial needle aspiration using 22G and 25G aspiration needles for lung cancer
Date of disclosure of the study information 2019/05/08
Last modified on 2019/05/08

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Basic information
Public title The prospective randomized controlled trial of endbronchial ultrasound-guided transbronchial needle aspiration using 22G and 25G aspiration needles for lung cancer
Acronym TBNA needle study
Scientific Title The prospective randomized controlled trial of endbronchial ultrasound-guided transbronchial needle aspiration using 22G and 25G aspiration needles for lung cancer
Scientific Title:Acronym TBNA needle study
Region
Japan

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

Objectives
Narrative objectives1 To compare the efficacy of the 25G EBUS-TBNA needle with the Expect Pulmonary 22G EBUS-TBNA needle
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The result of comparing of the the diagnostic accuracy of EBUS-TBNA with a 22-gauge and a 25-gauge aspiration needle in the historogically diagnosis of malignant tumor
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 First biopsy is performed using 22G needle by trainer
Second biopsy is performed using 25G needle by trainee
Interventions/Control_2 First biopsy is performed using 22G needle by trainee
Second biopsy is performed using 25G needle by trainer
Interventions/Control_3 First biopsy is performed using 25G needle by trainer
Second biopsy is performed using 22G needle by trainee
Interventions/Control_4 First biopsy is performed using 25G needle by trainee
Second biopsy is performed using 22G needle by trainer
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 1. Suspected lung cancer based on chest CT or already diagnosised of lung cancer
2.Patients with EBUS-TBNA puncturable mediastinal and hilar lymphadenopathy with 10 or more of short diameter by chest CT or SUV-max 2.5 or more by PET-CT.
3.Patients who have mediastinal and hilar lymphadenopathy suspected to have obvious lung cancer lymph node metastasis
4.Patients in need of tissue biopsy with EBUS-TBNA.
5.Patients with an age of 20 years or older
6.Patients who obtained written informed consent
Key exclusion criteria 1.Patients who need multiple lymph node punctures.
2.Patients with hypersensitivity to lidocaine, midazolam, flumazenil, pethidine hydrochloride, or patients with severe hypersensitivity to other drugs.
3.Patients who have clinical symptoms that are interfere in performing bronchoscopy.
4.Patients using antiplatelet drugs or anticoagulants. (It is acceptable if there is an appropriate withdrawal period)
5.Patients judged to be inappropriate by the attending physician.
6.Patients who have participated in this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Goto
Organization National Cancer Center Hospital East
Division name Depertment of Thoracic Oncology
Zip code 277-8577
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
TEL 0471331111
Email kgoto@east.ncc.go.jp

Public contact
Name of contact person
1st name Tetsuya
Middle name
Last name Sakai
Organization National Cancer Center Hospital East
Division name Depertment of Thoracic Oncology
Zip code 277-8577
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
TEL 0471331111
Homepage URL
Email tetsakai@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Depertment of Thoracic Oncology
Institute
Department

Funding Source
Organization National Cancer Center Hospital East
Depertment of Thoracic Oncology
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 National Cancer Center Hospital East Certified Review Board
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
Tel 04-7133-1111
Email ncche-irb@east.ncc.go.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
2019 Year 05 Month 08 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
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 Open public recruiting
Date of protocol fixation
2018 Year 06 Month 01 Day
Date of IRB
2018 Year 06 Month 01 Day
Anticipated trial start date
2018 Year 11 Month 08 Day
Last follow-up date
2020 Year 12 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 08 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041787

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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