UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031599 |
|---|---|
| Receipt number | R000036076 |
| Scientific Title | The efficacy of CPAP with endobronchial ultrasonography using a guide sheath for peripheral pulmonary small lesions |
| Date of disclosure of the study information | 2018/03/06 |
| Last modified on | 2018/04/17 01:11:11 |
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Basic information
Public title
The efficacy of CPAP with endobronchial ultrasonography using a guide sheath for peripheral pulmonary small lesions
Acronym
The efficacy of CPAP with endobronchial ultrasonography using a guide sheath for peripheral pulmonary small lesions
Scientific Title
The efficacy of CPAP with endobronchial ultrasonography using a guide sheath for peripheral pulmonary small lesions
Scientific Title:Acronym
The efficacy of CPAP with endobronchial ultrasonography using a guide sheath for peripheral pulmonary small lesions
Region
| Japan |
Condition
Condition
peripheral pulmonary small lesions
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify usefulness and safety of the CPAP with transbronchial biopsy using endobronchial ultrasound with a guide sheath for small peripheral lung lesions
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diagnostic rate of biopsy against peripheral pulmonary small lesions less than 2cm, using the CPAP and endobronchial ultrasound with a guide sheath
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Tracheal intubation and using CPAP during examination with bronchoscope
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.The case that a document agreement by the free will of the person was provided on enough understanding after having received enough explanation on participating of this study
2.It is a case younger than 90 years 20 years old or older at the time of the agreement acquisition
3.Longer axis 2cm or less of the target lesion in the chest CT
4.The case that thin slice CT less than slice thickness 2mm is photographed in examination with bronchoscope precordial region CT
Key exclusion criteria
1.The case with pneumothorax that is clear before inspection.
2.The case that is complicated with respiratory failure (PaO2 <60torr)
3.The case that blood pressure is less than 80mmHg by the vital measurement just before the examination with bronchoscope start.
4.In addition, the case that a study partaker judged to be inappropriate
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Imaizumi |
Organization
Fujita Health University
Division name
Department of Respiratory Medicine
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho Toyoake, Aichi Japan
TEL
0562-93-9241
jeanluc@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Minezawa |
Organization
Fujita Health University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho Toyoake, Aichi Japan
TEL
0562-93-9241
Homepage URL
minezawa@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 16 | 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 | 03 | Month | 06 | Day |
Last modified on
| 2018 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036076
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
