UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014289 |
|---|---|
| Receipt number | R000016640 |
| Scientific Title | Usefulness of bronchoscopy in combination with endobronchial ultrasonography, ultrafast papanicolaou stain, and virtual bronchoscopic navigation |
| Date of disclosure of the study information | 2014/06/17 |
| Last modified on | 2017/08/09 15:15:59 |
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Basic information
Public title
Usefulness of bronchoscopy in combination with endobronchial ultrasonography, ultrafast papanicolaou stain, and virtual bronchoscopic navigation
Acronym
usefulness of triple combination device in bronchoscopy
Scientific Title
Usefulness of bronchoscopy in combination with endobronchial ultrasonography, ultrafast papanicolaou stain, and virtual bronchoscopic navigation
Scientific Title:Acronym
usefulness of triple combination device in bronchoscopy
Region
| Japan |
Condition
Condition
peripheral pulmonary nodule
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
evaluation of usefullness of virtual bronchoscopy, EBUS-GS, ultrafast papanicolaou stain for diagnosis of peripheral pulmonary nodules
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
diagnostic yield
Key secondary outcomes
examination time, number of biopsy , complications
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
endobronchial ultrasonography, ultrafast papanicolaou stain, and virtual bronchoscopic navigation
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
1)Peripheral nodule cases of 3 cm or less chest CT
2)Cases that can be pointed out that shadow on chest radiograph
3)Cases a direct visualization not endoscopically
4)Cases consent was obtained in writing to the person or family
Key exclusion criteria
1)Heart failure patients and severe arrhythmia
2)Severe cases respiratory failure, chronic respiratory failure cases
3)Cases are complicated by respiratory active infection
4)Cases of lidocaine allergy
5)Pneumothorax cases
6)Patients have a bleeding tendency
7)Cases can not be obtained the cooperation of the patient
8)Other cases principal investigator was deemed inappropriate as the object of the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chikatoshi Sugimoto |
Organization
National Hospital Organization Kinki-chuo Chest Medical Center
Division name
Internal Medicine
Zip code
Address
Nagasone-cho 1180, Kita-ku, Sakai City Osaka 591-8555, Japan
TEL
072-252-3021
toshiya1027@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiya Maekura |
Organization
National Hospital Organization Kinki-chuo Chest Medical Center
Division name
Internal Medicine
Zip code
Address
Nagasone-cho 1180, Kita-ku, Sakai City Osaka 591-8555, Japan
TEL
072-252-3021
Homepage URL
toshiya1027@gmail.com
Sponsor or person
Institute
National Hospital Organization Kinki-chuo Chest Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kinki-chuo Chest Medical Center
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
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
| 2014 | Year | 06 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://jtd.amegroups.com/article/view/14702
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
| 2014 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 17 | 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
| 2014 | Year | 06 | Month | 17 | Day |
Last modified on
| 2017 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016640
