UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009752 |
|---|---|
| Receipt number | R000011428 |
| Scientific Title | Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) versus combination of EBUS-TBNA and transesophageal endoscopic ultrasound with bronchoscope -guided fine needle aspiration (EUS-B-FNA) in the mediastinal staging of non-small cell lung cancer |
| Date of disclosure of the study information | 2013/01/12 |
| Last modified on | 2023/07/21 07:10:31 |
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Basic information
Public title
Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) versus combination of EBUS-TBNA and transesophageal endoscopic ultrasound with bronchoscope -guided fine needle aspiration (EUS-B-FNA) in the mediastinal staging of non-small cell lung cancer
Acronym
Randomized study of EBUS-TBNA versus EBUS-TBNA/EUS-B-FNA
Scientific Title
Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) versus combination of EBUS-TBNA and transesophageal endoscopic ultrasound with bronchoscope -guided fine needle aspiration (EUS-B-FNA) in the mediastinal staging of non-small cell lung cancer
Scientific Title:Acronym
Randomized study of EBUS-TBNA versus EBUS-TBNA/EUS-B-FNA
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of additional EUS-B-FNA in relation to EBUS-TBNA 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 III
Assessment
Primary outcomes
1. Sensitivity of EBUS-TBNA versus EBUS-TBNA/EUS-B-FNA
Key secondary outcomes
1. Negative predictive value, positive predictive value, specificity and accuracy of EBUS-TBNA versus EBUS-TBNA/EUS-B-FNA
2. Time of procedure
3. Frequency of adverse effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
EBUS-TBNA
Interventions/Control_2
Combination of EBUS-TBNA and EUS-B-FNA
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 suspected or proven non-small cell lung cancer who need confirmatory hilar/mediastinal staging for management decision
2. Patients having at least one of the 3 following items:
- Hilar/mediastinal lymph nodes (N1 or N2 or N3), 10 mm or greater in short-axis diameter on CT
- PET-positive hilar/mediastinal lymph nodes (N1 or N2 or N3)
- Central tumor
- Primary tumor size >= 30 mm
- Primary tumor without FDG uptake
3. 20 years old or more
4. Informed consent
Key exclusion criteria
1. Patients with obvious unresectable lung cancer (e.g. distant metastases, mediastinal invasion, bulky N2/N3)
2. Patients for whom lymphadenectomy or surgical hilar/mediastinal staging will be difficult to undergo
3. Patients with recurrent lung cancer
4. Pregnant woman
5. Bleeding tendency
6. Other presumed difficulties for patients in this study
Target sample size
240
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@gmail.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
| 2013 | Year | 01 | Month | 12 | 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
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 10 | Day |
Last modified on
| 2023 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011428
