UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004397 |
|---|---|
| Receipt number | R000002530 |
| Scientific Title | Comparison of Airway Measurements using Stereoscopic Bronchoscopy, Endobronchial Ultrasonography and Multi-Detector CT. |
| Date of disclosure of the study information | 2010/10/18 |
| Last modified on | 2020/03/21 13:01:58 |
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Basic information
Public title
Comparison of Airway Measurements using Stereoscopic Bronchoscopy, Endobronchial Ultrasonography and Multi-Detector CT.
Acronym
Airway Measurements using Stereoscopic Bronchoscopy, EBUS and MDCT
Scientific Title
Comparison of Airway Measurements using Stereoscopic Bronchoscopy, Endobronchial Ultrasonography and Multi-Detector CT.
Scientific Title:Acronym
Airway Measurements using Stereoscopic Bronchoscopy, EBUS and MDCT
Region
| Japan |
Condition
Condition
air way disease
Classification by specialty
| Medicine in general | Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Endobronchial Ultrasonography (EBUS) and Stereoscopic Bronchoscopy can assess the endobronchial area and peri-bronchial structure revealing abnormal findings in the central airways via brochoscopy. These techniques can be used to assess the diameter and length of the affected airway. We then compared findings of the EBUS images and Stereoscopic Bronchoscopy with MDCT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endobronchial Ultrasonography (EBUS) and Stereoscopic Bronchoscopy can assess the endobronchial area and peri-bronchial structure revealing abnormal findings in the central airways via brochoscopy. These techniques can be used to assess the diameter and length of the affected airway. We then compared findings of the EBUS images and Stereoscopic Bronchoscopy with MDCT.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Consecutive patients with airway disease who visited our institution. Eligible patients met the following criteria: those with respiratory tract symptoms with limited life expectancy due to airway disease, those who gave written informed consent to participate in this study.
Key exclusion criteria
Patients were excluded from this study if dyspnea was too severe to obtain CT findings, unable to receive EBUS and bronchoscope due to excessive bleeding, and patients deemed as unfit to enter the study by physician.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiichi.Nobuyama |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory and Infectious Diseases, Department of Internal Medicine,
Zip code
Address
Sugou 2-16-1, Miyamae-ku, Kawasaki City, Kanagawa
TEL
044-977-8111
nobuyama@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiichi.Nobuyama |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory and Infectious Diseases, Department of Internal Medicine,
Zip code
Address
Sugou 2-16-1, Miyamae-ku, Kawasaki City, Kanagawa
TEL
044-977-8111
Homepage URL
nobuyama@zeus.eonet.ne.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
聖マリアンナ医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 18 | 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
| 2009 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2009 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2010 | Year | 10 | Month | 17 | Day |
Last modified on
| 2020 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002530
| Research Plan | |
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| 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 |
