Unique ID issued by UMIN | UMIN000000506 |
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Receipt number | R000000614 |
Scientific Title | A phase II study of real-time endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) with rapid on-site cytologic evaluation (ROSE) in the diagnosis of lung cancer |
Date of disclosure of the study information | 2006/11/01 |
Last modified on | 2013/01/02 06:26:13 |
A phase II study of real-time endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) with rapid on-site cytologic evaluation (ROSE) in the diagnosis of lung cancer
EBUS-TBNA with ROSE in the diagnosis of lung cancer
A phase II study of real-time endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) with rapid on-site cytologic evaluation (ROSE) in the diagnosis of lung cancer
EBUS-TBNA with ROSE in the diagnosis of lung cancer
Japan |
Lung cancer
Pneumology |
Malignancy
NO
The purpose of this study is to evaluate the diagnostic utility of EBUS-TBNA with ROSE in patients with suspected lung cancer presenting with enlarged hilar-mediastinal nodes or tumors.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Diagnostic yield
1. Frequency of adverse effects 2. The accuracy of EBUS-TBNA for diagnosing malignancy 3. The accuracy of ROSE for predicting final diagnosis of malignancy
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients with suspected malignancy who need to undergo diagnostic bronchoscopy 2. Hilar-mediastinal lesions 10 mm or greater in short-axis diameter on chest computed tomography 3. 20 years and above 4. Informed consent
1. Patients with known lung cancer 2. Pregnancy 3. Other clinical difficulties in this study
110
1st name | |
Middle name | |
Last name | Masahide Oki |
Nagoya Medical Center
Department of Respiratory Medicine
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
052-951-1111
1st name | |
Middle name | |
Last name | Masahide Oki |
Nagoya Medical Center
Department of Respiratory Medicine
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
052-951-1111
Masahideo@aol.com
Nagoya Medical Center
Cancer Research, Ministry of Health, Labour and Welfare
Japan
NO
国立病院機構名古屋医療センター
2006 | Year | 11 | Month | 01 | Day |
Unpublished
EBUS-TBNA with ROSE for hilar-mediastinal lesions established a specific diagnosis in 63 of all 81 patients (78%) examined, and in 55 of 64 (86%) in whom lung cancer was diagnosed without any complications. The ROSE results allowed the avoidance of additional bronchoscopic procedures in 53 of 81 patients (65%). Although four false-positive results and two false-negative results (accuracy; 93%) occurred in predicting the final diagnosis of malignancy by ROSE on EBUS-TBNA, the misdiagnosis by ROSE did not cause any significant adverse effects on patient care.
Completed
2004 | Year | 03 | Month | 01 | Day |
2004 | Year | 07 | Month | 01 | Day |
2006 | Year | 11 | Month | 01 | Day |
Observation of the utility of EBUS-TBNA utilizing ROSE for diagnosis in patients with enlarged hilar-mediastinal lesions suspected of lung cancer
2006 | Year | 10 | Month | 30 | Day |
2013 | Year | 01 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000614
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