UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002882 |
|---|---|
| Receipt number | R000003517 |
| Scientific Title | Phase II study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and transesophageal bronchoscopic ultrasound-guided fine needle aspiration (TEBUS-FNA) using an EBUS bronchoscope in the mediastinal staging of non-small cell lung cancer |
| Date of disclosure of the study information | 2009/12/12 |
| Last modified on | 2015/02/16 09:15:00 |
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Basic information
Public title
Phase II study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and transesophageal bronchoscopic ultrasound-guided fine needle aspiration (TEBUS-FNA) using an EBUS bronchoscope in the mediastinal staging of non-small cell lung cancer
Acronym
EBUS-TBNA and TEBUS-FNA for mediastinal staging
Scientific Title
Phase II study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and transesophageal bronchoscopic ultrasound-guided fine needle aspiration (TEBUS-FNA) using an EBUS bronchoscope in the mediastinal staging of non-small cell lung cancer
Scientific Title:Acronym
EBUS-TBNA and TEBUS-FNA for mediastinal staging
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the accuracy and safety on EBUS-TBNA and TEBUS-FNA using an EBUS bronchoscope in the mediastinal staging of non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
1. Accuracy of EBUS-TBNA and/or TEBUS-FNA
Key secondary outcomes
1. Accuracy of non-invasive modalities (PET, CT)
2. Time of procedure
3. Frequency of adverse effects
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
EBUS-TBNA and TEBUS-FNA for patients with non-small cell lung cancer
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. Patients with potentially operable, suspected or proven non-small cell lung cancer
2. 20 years old or more
3. Informed consent
Key exclusion criteria
1. Patients with recurrent lung cancer
2. Bleeding tendency
3. Pregnant woman
4. Other clinical difficulties in this study
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahide Oki |
Organization
Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL
052-951-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahide Oki |
Organization
Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL
052-951-1111
Homepage URL
masahideo@aol.com
Sponsor or person
Institute
Nagoya Medical Center
Institute
Department
Personal name
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
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
国立病院機構 名古屋医療センター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.jtcvsonline.org/article/S0022-5223(14)00560-1/abstract
Number of participants that the trial has enrolled
Results
EBUS-TBNA was performed for 257 lymph nodes, and EUS-FNA for 176 lymph nodes. A total of 146 patients had a final diagnosis of non-small cell lung cancer. Thirty-three of them (23%) had N2 and/or N3 node metastases. The sensitivity of EBUS-TBNA, EUS-FNA and the combined approach per patient was 52%, 45% and 73%, respectively (EBUS-TBNA vs combined approach: p = 0.016 using McNemar test). The negative predictive value was 88%, 86% and 93%, respectively. Two cases (1%) of severe cough resulted from EBUS-TBNA.
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
| 2009 | Year | 10 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 11 | Day |
Last modified on
| 2015 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003517
