UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031389 |
|---|---|
| Receipt number | R000034788 |
| Scientific Title | Comparison of thin and standard aspiration needle in endobronchial urtlasound-guided transbronchial aspiration |
| Date of disclosure of the study information | 2018/02/20 |
| Last modified on | 2018/12/28 15:16:48 |
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Basic information
Public title
Comparison of thin and standard aspiration
needle in endobronchial urtlasound-guided transbronchial aspiration
Acronym
Comparison of aspiration needle in EBUS-TBNA
Scientific Title
Comparison of thin and standard aspiration
needle in endobronchial urtlasound-guided transbronchial aspiration
Scientific Title:Acronym
Comparison of aspiration needle in EBUS-TBNA
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the diagnostic adequacy between 25G
aspiration needle and 22G aspiration needle
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of the diagnostic adequacy between 25G aspiration needle and 22G aspiration needle
Key secondary outcomes
Rate of histological core tissue procurement,
quality of histological core tissue, treatment time, adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform EBUS-TBNA with two passes using 25G EchoTip ProCore neeedle.
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
Patients with hilar and mediastinal lymphadenopathy
Key exclusion criteria
Patients judged inappropriate by the attending
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kozo yoshimori |
Organization
Fukujuji Hospital, Japan Anti-Tubeculosis Association
Division name
Department of respiratory medicine
Zip code
Address
Matsuyama, 3-1-24, Kiyose-shi, Tokyo, Japan
TEL
042-491-4111
yoshimorik@fukujuji.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kozo Yoshimori |
Organization
Fukujuji Hospital, Japan Anti-Tubeculosis Association
Division name
Department of respiratory medicine
Zip code
Address
Matsuyama, 3-1-24, Kiyose-shi, Tokyo, Japan
TEL
042-491-4111
Homepage URL
yoshimorik@fukujuji.org
Sponsor or person
Institute
Fukujuji Hospital, Japan Anti-Tubeculosis Association
Institute
Department
Personal name
Funding Source
Organization
Fukujuji Hospital, Japan Anti-Tubeculosis Association
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
公益財団法人結核予防会複十字病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 20 | 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
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 20 | Day |
Last modified on
| 2018 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034788
