UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055839 |
|---|---|
| Receipt number | R000063816 |
| Scientific Title | Investigation of the effectiveness of positional changes in bronchoscopy. |
| Date of disclosure of the study information | 2024/10/15 |
| Last modified on | 2024/10/15 14:56:30 |
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Basic information
Public title
Investigation of the effectiveness of positional changes in bronchoscopy.
Acronym
Investigation of the effectiveness of positional changes in bronchoscopy.
Scientific Title
Investigation of the effectiveness of positional changes in bronchoscopy.
Scientific Title:Acronym
Investigation of the effectiveness of positional changes in bronchoscopy.
Region
| Japan |
Condition
Condition
peripheral pulmonary lesion
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the usefulness in bronchoscopy in the position with the lesion site on the upper side during bronchoscopy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare bronchial order and bronchial inner diameter to lesions in the supine and side lying positions using VINCENT and virtual images.
Key secondary outcomes
1. Comparison of lung lobe volumes in the supine and lateral recumbent positions
Measured using VINCENT
2. Bronchoscopy in supine and lateral recumbent position
Agreement with VINCENT and virtual images
Insertion bronchial site and order
Observed bronchus site and order
3. EBUS findings
4. Combi-beam CT findings and number of imaging
Diagnosis rate
Diagnosis rate (culture, cytology, and histology combined) and tissue diagnosis rate
Diagnosis rate by final diagnosis (benign/malignant)
Diagnosis rate by lesion size (2 cm or smaller)
Diagnosis rate by distance of lesion from the pulmonary hilum (middle 1/3, outer 1/3)
Diagnosis rate by lung lobe
Diagnosis rate by presence or absence of involved bronchus
6. Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
1) Before performing the examination, a chest CT scan is taken in the supine and lateral recumbent positions to create virtual bronchoscopic images; CT analysis software (VINCENT) is used to compare bronchial order numbers, measure bronchial inner diameter, and compare lung lobe volumes.
2) During bronchoscopy, the patient is initially placed in the supine position for observation of the lumen, followed by positioning the patient with the lesion on the upper side for observation and treatment of the lumen. The bronchoscope is advanced toward the lesion according to the virtual bronchoscopic navigation (VBN) system (DirectPath R), and the radial ultrasound probe is advanced through the forceps channel after getting as close to the lesion as possible, The lesion is visualized by endobronchial ultrasonography (EBUS). The number of bronchioles that can be observed is recorded, and whether the lesion can be reached or endoscopically diagnosed is evaluated. Once the lesion is visualized, the ultrasound probe is considered to have reached the lesion and the ultrasound probe is replaced with the biopsy forceps. After confirming that the biopsy forceps have reached the lesion, forceps biopsy, brush scraping, and cleaning are performed under fluoroscopy.
3) If the lesion cannot be delineated by EBUS, a combi-beam CT is performed if necessary. If the lesion is visualized by EBUS, the same procedure as described in 2) should be performed. As a safety measure, secure the examination personnel and immobilize the patient's position with a suppression band, etc. At the end of bronchoscopy, the patient should be returned to the supine position to complete the examination.
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) Patients requiring bronchoscopy for lung cancer, pneumonia, etc.
2) Patients must have peripheral lesions.
3) Must be at least 20 years old.
4) SpO2 greater than 90%.
5) Written consent to participate in the study has been obtained from the patient.
Key exclusion criteria
1) Cases in which bronchoscopy seems to show lesions more central than the subareolar branch.
2) Patients with serious complications that may interfere with the examination.
3) Pregnant women.
4) Patients with other complications that may seriously interfere with the performance of the examination.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Fumihiro |
| Middle name | |
| Last name | Asano |
Organization
Gifu Prefectural General Medical Center
Division name
Respiratory Medicine
Zip code
500-8717
Address
4-6-1 Noisshiki, Gifu City, Gifu, Japan.
TEL
058-246-1111
ykuzu0712@gamil.com
Public contact
Name of contact person
| 1st name | Yutaro |
| Middle name | |
| Last name | Kuzunishi |
Organization
Gifu Prefectural General Medical Center
Division name
Respiratory Medicine
Zip code
500-8717
Address
4-6-1 Noisshiki, Gifu City, Gifu, Japan
TEL
058-246-1111
Homepage URL
ykuzu0712@gmail.com
Sponsor or person
Institute
Gifu Prefectural General Medical Center
Institute
Department
Personal name
Kuzunishi Yutaro
Funding Source
Organization
Non
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
Gifu Prefectural General Medical Center
Address
4-6-1 Noisshiki, Gifu City, Gifu, Japan
Tel
058-246-1111
ykuzu0712@gmail.com
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
| 2024 | Year | 10 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 15 | Day |
Last modified on
| 2024 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063816
