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Japanese

July. 08, 2020

Mar. 12, 2021

jRCT1032200065

An observational study: the diagnostic feasibility using a new single-use cryoprobe for peripheral pulmonary lesions

Diagnostic feasibility using a new cryoprobe for peripheral pulmonary lesions

Tanaka Midori

National Cancer Center Hospital

5-1-1 Tsukiji, Chuo-ku, Tokyo

+81-3-3542-2511

midotana@ncc.go.jp

Tanaka Midori

National Cancer Center Hospital

5-1-1 Tsukiji, Chuo-ku, Tokyo

+81-3-3542-2511

midotana@ncc.go.jp

Not Recruiting

July. 08, 2020

July. 15, 2020
50

Observational

1) Patients planning to undergo cryobiopsy for peripheral pulmonary lesions suspected of lung malignant neoplasms based on clinical signs and radiological images
2) Patients with a high-resolution CT scan performed within 1 month of the entry and the images fulfill the following three points
i) A long diameter of 30 mm or less on the axial view
ii) A solitary pulmonary nodule
iii) A lesion locating beyond the subsegmental bronchus
3) Patients with no treatment history (i.e., surgery, radiation therapy, antitumor drugs, and so on) for the target lesion
4) Patients not younger than 20-year-old at the time of informed consent
5) Patients discontinuing anticoagulants and/or antiplatelet agents if used
6) Patients providing written informed consent

1) Patients with a treatment history (i.e., surgery, radiation therapy, antitumor drugs, and so on) for the same side as the target lesion
2) Patients with a tracheostoma
3) Patients with poorly controlled mental disorders and/or dementia
4) Patients deemed unsuitable for inclusion in the study for any other reason based on the assessment by the investigators

20age old over
No limit

Both

Lung neoplasms

Lung neoplasms

D008175

diagnostic yield (sensitivity)

safety, specificity and accuracy, procedure duration, diagnostic yield by each sampling, microscopic evaluation for each tissue sample, diagnostic possibility by each tissue sample, and cumulative sensitivity

National Cancer Center Institutional Review Board
5-1-1 Tsukiji, Chuo-ku, Tokyo

+81-3-3542-2511

ncch-irb@ml.res.ncc.go.jp
Approval

No

none

History of Changes

No Publication date
3 Mar. 12, 2021 (this page) Changes
2 July. 17, 2020 Detail Changes
1 July. 08, 2020 Detail