UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024305 |
|---|---|
| Receipt number | R000027994 |
| Scientific Title | Randomized study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy (TBB) with virtual bronchoscopic navigation (VBN) for the diagnosis of small peripheral pulmonary lesions: guide sheath (GS) method vs. non-guide sheath method (Non-GS) |
| Date of disclosure of the study information | 2016/10/06 |
| Last modified on | 2021/10/21 23:10:41 |
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Basic information
Public title
Randomized study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy (TBB) with virtual bronchoscopic navigation (VBN) for the diagnosis of small peripheral pulmonary lesions: guide sheath (GS) method vs. non-guide sheath method (Non-GS)
Acronym
Comparison of GS vs. Non-GS method during EBUS-TBB
Scientific Title
Randomized study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy (TBB) with virtual bronchoscopic navigation (VBN) for the diagnosis of small peripheral pulmonary lesions: guide sheath (GS) method vs. non-guide sheath method (Non-GS)
Scientific Title:Acronym
Comparison of GS vs. Non-GS method during EBUS-TBB
Region
| Japan |
Condition
Condition
Benign or malignant pulmonary lesions
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the diagnostic yield of EBUS-TBB-VBN with and without a GS for the diagnosis of small peripheral pulmonary lesions
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
1. Diagnostic yield of histology specimens
Key secondary outcomes
1. Overall diagnostic yield of the combination of culture, cytology, and histology specimens
2. Diagnostic yield: benign or malignant
3. Diagnostic yield according to lesion size: < 20 mm or > 20 mm
4. Diagnostic yield according to lesion location relative to the hilum: middle third ellipse or outer third ellipse
5. Diagnostic yield according to lesion location in the bronchopulmonary segment
6. Visibility with EBUS
7. Diagnostic yield according to the probe location relative to the target lesion
8. Diagnostic yield according to the presence of the air bronchus sign
9. Diagnostic yield according to lesion appearance on computed tomography (CT): solid or ground glass nodule
10. Level of bronchus reached
11. Time taken for examination procedure
12. Incidence 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-TBB-VBN with GS
Interventions/Control_2
EBUS-TBB-VBN without GS
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 a peripheral pulmonary lesion < 30 mm in size who need to undergo diagnostic bronchoscopy
2. 20 years old or older
3. Informed consent
Key exclusion criteria
1. Serious concomitant medical illness
2. Central pulmonary lesions
3. Lesion located within the inner third ellipse from the hilum on chest CT
4. Re-examination following prior failure in this trial
5. Case with pure ground glass nodule
6. Patients needing to undergo bronchoscopic procedures for non-target lesion in the same setting
7. Diffuse pulmonary lesions
8. Pregnancy
9. Bleeding tendency
10. Other clinical difficulties in this trial
Target sample size
600
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
masahideo@gmail.com
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
Self-funding
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
| 2016 | Year | 10 | Month | 06 | 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
| 2016 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 06 | 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
| 2016 | Year | 10 | Month | 05 | Day |
Last modified on
| 2021 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027994
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