UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039033 |
|---|---|
| Receipt number | R000044510 |
| Scientific Title | Observation of azygos vein valve by endobronchial ultrasonography |
| Date of disclosure of the study information | 2020/01/06 |
| Last modified on | 2023/01/02 15:51:26 |
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Basic information
Public title
Observation of azygos vein valve by endobronchial ultrasonography
Acronym
Observation of azygos vein by EBUS
Scientific Title
Observation of azygos vein valve by endobronchial ultrasonography
Scientific Title:Acronym
Observation of azygos vein by EBUS
Region
| Japan |
Condition
Condition
Patients receiving EBUS
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether azygos vein valve can be observed with EBUS
Basic objectives2
Others
Basic objectives -Others
Anatomic feature
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether azygos vein valve can be observed with EBUS
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Receiving EBUS
2) Aged 20 or more
3) Written informed consent
Key exclusion criteria
1) Nothing particular
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Nakashima |
Organization
Shimane University Faculty of Medicine
Division name
Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane, Japan
TEL
0853-20-2580
kazuhin@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Nakashima |
Organization
Shimane University Faculty of Medicine
Division name
Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane, Japan
TEL
0853-20-2580
Homepage URL
kazuhin@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
The institutional review board of Shimane University Faculty of Medicine
Address
89-1 Enya-cho, Izumo, Shimane, Japan
Tel
0853-20-2515
kenkyu@med.shimane-u.ac.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
| 2020 | Year | 01 | 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
20
Results
The median age was 71.5 years. Observation of azygos vein arch was performed in 16 patients. The median length of azygos vein arch was 7.25 millimeter. Valves were identified in all 16 patients. We observed the inside of other vessels around trachea. However, there were no valve in these vessels.
Results date posted
| 2023 | Year | 01 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age was 71.5 years. The study included 18 men and 2 women.
Participant flow
Eligible patients were enrolled from February through September 2020. EBUS was not performed as a result in 2 patients because enough tissue was obtained with normal bronchoscopy. Azygos vein arch was not visualized in 2 patients. Therefore, observation of azygos vein arch was performed in 16 patients.
Adverse events
None.
Outcome measures
Observation of azygos vein arch was performed in 16 patients. The median length of azygos vein arch was 7.25 millimeter. In all 16 patients, azygous vein arch valve could be observed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing particular.
Management information
Registered date
| 2019 | Year | 12 | Month | 30 | Day |
Last modified on
| 2023 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044510
| 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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