UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034705 |
|---|---|
| Receipt number | R000039570 |
| Scientific Title | An observational study for comparison of diagnostic yield, maneuverability and safety between 22-gauge and 25-gauge needles for endobronchial ultrasound-guided transbronchial needle aspiration. |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2023/11/06 10:39:17 |
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Basic information
Public title
An observational study for comparison of diagnostic yield, maneuverability and safety between 22-gauge and 25-gauge needles for endobronchial ultrasound-guided transbronchial needle aspiration.
Acronym
An observational study for comparison of diagnostic yield, maneuverability and safety between 22-gauge and 25-gauge needles for endobronchial ultrasound-guided transbronchial needle aspiration.
Scientific Title
An observational study for comparison of diagnostic yield, maneuverability and safety between 22-gauge and 25-gauge needles for endobronchial ultrasound-guided transbronchial needle aspiration.
Scientific Title:Acronym
An observational study for comparison of diagnostic yield, maneuverability and safety between 22-gauge and 25-gauge needles for endobronchial ultrasound-guided transbronchial needle aspiration.
Region
| Japan |
Condition
Condition
malignant and benign mediastinal hilar lymphadenopathy.
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To comparison of diagnostic yield, maneuverability and safety between 22-gauge and 25-gauge needles for endobronchial ultrasound-guided transbronchial needle aspiration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the diagnostic yield between 22-gauge and 25-gauge needles for endobronchial ultrasound-guided transbronchial needle aspiration.
Key secondary outcomes
Comparison of the diagnostic yield based on malignant and benign regions, histological diagnostic yield and cytological diagnostic yield, quantity of histological core tissue, maneuverability, safety
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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.
20 years old and above
Key exclusion criteria
Patients who are considered as inappropriate by physician.
Rebiopsy to detect resistance mutation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Sakaguchi |
Organization
Matsusaka Municipal Hospital
Division name
Department of respiratory medicine
Zip code
515-8544
Address
1550, Tonomachi, Matsusaka, Mie, 515-0073, Japan
TEL
0598-23-1515
mchsakaguchi@city-hosp.matsusaka.mie.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Sakaguchi |
Organization
Matsusaka Municipal Hospital
Division name
Department of respiratory medicine
Zip code
515-8544
Address
1550, Tonomachi, Matsusaka, Mie, 515-0073, Japan
TEL
0598-23-1515
Homepage URL
mchsakaguchi@city-hosp.matsusaka.mie.jp
Sponsor or person
Institute
Matsusaka Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Matsusaka Municipal Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsusaka municipal hospital
Address
1550, Tonomachi, Matsusaka, Mie,
Tel
0598-23-1515
mch1031@city-hosp.matsusaka.mie.jp
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
| 2018 | Year | 11 | Month | 01 | 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
60
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
Main results already published
Date of protocol fixation
| 2018 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
preparing the results of the study
Management information
Registered date
| 2018 | Year | 10 | Month | 30 | Day |
Last modified on
| 2023 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039570
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
