Unique ID issued by UMIN | UMIN000031270 |
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Receipt number | R000035658 |
Scientific Title | Usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions |
Date of disclosure of the study information | 2018/02/15 |
Last modified on | 2022/08/18 09:09:50 |
Usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions
Usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions
Usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions
Usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions
Japan |
Benign or malignant pulmonary lesions
Pneumology |
Malignancy
NO
The usefulness of cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy of peripheral pulmonary lesions will be investigated.
Safety,Efficacy
Rate of reaching the lesion and rate of cases for which cone beam CT was effective
1. DirectPath
Regions and the bronchial generation order for which virtual images are automatically prepared
Regions and the bronchial generation order for which manual imaging is added
2. Bronchoscopy
Consistency with virtual images
Region and the bronchial generation order allowing insertion
Region and the bronchial generation order observed
3. EBUS
Findings: within, adjacent to, invisible
4. Cone beam CT
Findings: centered, inside, and outside
Number of acquisitions
5. Diagnostic yield
Diagnostic yield (histological diagnostic yield and overall diagnostic yield combining culture, cytology, and histological diagnosis)
Diagnostic yield by the final diagnosis (benign, malignant)
Diagnostic yield by the lesion size (larger or smaller than 2 cm)
Diagnostic yield by the distance of the lesion from the pulmonary hilum (1/3 intermediate, 1/3 lateral)
Diagnostic yield by the pulmonary lobe
Diagnostic yield by the presence or absence of involved bronchus
Diagnostic yield by the character of the lesion (solid, ground glass nodule)
Diagnostic yield by cone beam CT findings
6. Examination and fluoroscopy time and X-ray exposure
Bronchoscopic examination time
Total fluoroscopy time
Cumulative dose area product (DAP) (fluoroscopy, acquisition)
Cumulative Frontal Air Kerma
7. Safety
Complications
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Device,equipment |
Cone beam CT for virtual bronchoscopic navigation-combined ultrathin bronchoscopy
20 | years-old | <= |
Not applicable |
Male and Female
1) A 3-cm or smaller peripheral pulmonary lesion is present on chest CT and bronchoscopic examination is necessary to diagnose it or decide on a treatment strategy.
2) The bronchus or pulmonary artery involved in the lesion can be confirmed on chest CT.
3) Age of 20 years old or older
4) SpO2 of 90% or higher
5) Obtainment of written consent to participation in the study directly from the patients.
1) A lesion is considered present on the central side of the subsegmental bronchus on bronchoscopy.
2) It is clear that the lesion is benign on imaging such as CT.
3) The presence of serious complication which may interfere with examination
4) Oral medication with anticoagulant and antiplatelet agent unable to be discontinued
5) Pregnancy
6) The presence of another complication which may seriously interfere with execution of the examination.
40
1st name | Fumihiro |
Middle name | |
Last name | Asano |
Gifu Prefectural General Medical Center
Department of Pulmonary Medicine
5008717
4-6-1, Noishiki, Gifu, Japan
058-246-1111
asano-fm@ceres.ocn.ne.jp
1st name | Fumihiro |
Middle name | |
Last name | Asano |
Gifu Prefectural General Medical Center
Department of Pulmonary Medicine
5008717
4-6-1, Noishiki, Gifu, Japan
058-246-1111
asano-fm@ceres.ocn.ne.jp
Gifu Prefectural General Medical Center
Self-funding
Self funding
Gifu Prefectural General Medical Center
4-6-1
0582461111
asano-fm@ceres.ocn.ne.jp
NO
2018 | Year | 02 | Month | 15 | Day |
Unpublished
Open public recruiting
2018 | Year | 02 | Month | 07 | Day |
2018 | Year | 02 | Month | 15 | Day |
2018 | Year | 02 | Month | 13 | Day |
2022 | Year | 08 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035658
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