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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001280
Receipt No. R000001558
Scientific Title A feasibility study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in evaluation of mediastinal nodal metastasis of lung cancer
Date of disclosure of the study information 2008/07/31
Last modified on 2019/02/07

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Basic information
Public title A feasibility study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in evaluation of mediastinal nodal metastasis of lung cancer
Acronym EBUS-TBNA in N2-diagnosis of lung cancer
Scientific Title A feasibility study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in evaluation of mediastinal nodal metastasis of lung cancer
Scientific Title:Acronym EBUS-TBNA in N2-diagnosis of lung cancer
Region
Japan

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

Objectives
Narrative objectives1 To assess feasibility of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in evaluation of medaistinal nodal metastasis of lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Sensitivity of EBUS-TBNA in the diagnosis of mediastinal nodal metastasis
Key secondary outcomes Safety profile of EBUS-TBNA, Sensitivity and specificity of positron emission tomography (PET) in the diagnosis of mediastinal nodal metastasis

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 EBUS-TBNA is performed in lung cancer patients with suspicion of mediastinal nodal metastasis on chest CT
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 1, Resectable and previously untreated non-small cell lung cancer with clinical stage T1-3N0M0
2, Mediastinal nodal enlargement on chest CT (long-axis diameter is 3cm or shorter and enlarger mediastinal nodal station is one or two)
3, PS, 0-2
4, Good major organ function
5, Written informed consent
Key exclusion criteria 1, Active infection
2, Any other active malignant tumor
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiki Hasegawa
Organization Hyogo College of Medicine
Division name Thoracic surgery
Zip code
Address Mukogawa 1-1, Nishinomiya-city, Hyogo-prefacture, Japan
TEL 0798-45-6885
Email ftanaka@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumihiro Tanaka
Organization Hyogo College of Medicine
Division name Thoracic surgery
Zip code
Address Mukogawa 1-1, Nishinomiya-city, Hyogo-prefacture, Japan
TEL 0798-45-6885
Homepage URL http://www.jmto.org/trial/index.html
Email ftanaka@hyo-med.ac.jp

Sponsor
Institute Japan-multinational Trial Organization (JMTO)
Institute
Department

Funding Source
Organization Japan-multinational Trial Organization (JMTO)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2008 Year 07 Month 31 Day

Related information
URL releasing protocol http://www.jmto.org/index.html
Publication of results Published

Result
URL related to results and publications https://www.karger.com/Article/FullText/447989
Number of participants that the trial has enrolled
Results
EBUS-TBNA is a standard procedure for pathological evaluation of mediastinal nodal (N2) status of lung cancer, but its feasibility in potentially operable patients with suspicion of minimal N2 remains unestablished. A prospective multicenter study was conducted to assess the feasibility. Clinical stage-IIIA-N2 non-small cell lung cancer (NSCLC) patients with mediastinal nodal enlargement on CT were eligible; patients were ineligible when CT revealed bulky station N2. When EBUS-TBNA revealed negative results, surgical staging procedures were mandatory. Among 20 eligible patients, EBUS-TBNA provided pathological confirmation of N2 (true-positive) in 12 patients. Among 8 patients with negative results with EBUS-TBNA, 4 patients were pathologically diagnosed of N2 disease with surgical staging procedures (false-negative), and 4 were finally diagnosed of non-N2 disease with nodal dissection by thoracotomy (true-negative). As a result, the sensitivity of EBUS-TBNA for N2 evaluation, the primary endpoint, was 75.0%. There documented no Grade 3-5 adverse event.EBUS-TBNA is safe and useful in pathological evaluation of N2 status even in potentially operable NSCLC patients with suspicion of minimal N2 on preoperative CT.
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 Completed
Date of protocol fixation
2008 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2011 Year 02 Month 01 Day
Date of closure to data entry
2011 Year 02 Month 01 Day
Date trial data considered complete
2011 Year 02 Month 01 Day
Date analysis concluded
2011 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 07 Month 31 Day
Last modified on
2019 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001558

Research Plan
Registered date File name
2019/02/07 JMTO LC07-02プロトコル20080214版最終_.doc

Research case data specifications
Registered date File name
2019/02/07 コピーLC07-02_集計結果(再) 田中文啓修正20130527.xls

Research case data
Registered date File name
2019/02/07 投稿用最終判定結果要約20140620田中文啓.xls


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