Unique ID issued by UMIN | UMIN000036680 |
---|---|
Receipt number | R000041787 |
Scientific Title | The prospective randomized controlled trial of endbronchial ultrasound-guided transbronchial needle aspiration using 22G and 25G aspiration needles for lung cancer |
Date of disclosure of the study information | 2019/05/08 |
Last modified on | 2020/05/08 14:50:53 |
The prospective randomized controlled trial of endbronchial ultrasound-guided transbronchial needle aspiration using 22G and 25G aspiration needles for lung cancer
TBNA needle study
The prospective randomized controlled trial of endbronchial ultrasound-guided transbronchial needle aspiration using 22G and 25G aspiration needles for lung cancer
TBNA needle study
Japan |
Lung cancer
Pneumology |
Malignancy
NO
To compare the efficacy of the 25G EBUS-TBNA needle with the Expect Pulmonary 22G EBUS-TBNA needle
Efficacy
The result of comparing of the the diagnostic accuracy of EBUS-TBNA with a 22-gauge and a 25-gauge aspiration needle in the historogically diagnosis of malignant tumor
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
4
Diagnosis
Device,equipment |
First biopsy is performed using 22G needle by trainer
Second biopsy is performed using 25G needle by trainee
First biopsy is performed using 22G needle by trainee
Second biopsy is performed using 25G needle by trainer
First biopsy is performed using 25G needle by trainer
Second biopsy is performed using 22G needle by trainee
First biopsy is performed using 25G needle by trainee
Second biopsy is performed using 22G needle by trainer
20 | years-old | <= |
Not applicable |
Male and Female
1. Suspected lung cancer based on chest CT or already diagnosised of lung cancer
2.Patients with EBUS-TBNA puncturable mediastinal and hilar lymphadenopathy with 10 or more of short diameter by chest CT or SUV-max 2.5 or more by PET-CT.
3.Patients who have mediastinal and hilar lymphadenopathy suspected to have obvious lung cancer lymph node metastasis
4.Patients in need of tissue biopsy with EBUS-TBNA.
5.Patients with an age of 20 years or older
6.Patients who obtained written informed consent
1.Patients who need multiple lymph node punctures.
2.Patients with hypersensitivity to lidocaine, midazolam, flumazenil, pethidine hydrochloride, or patients with severe hypersensitivity to other drugs.
3.Patients who have clinical symptoms that are interfere in performing bronchoscopy.
4.Patients using antiplatelet drugs or anticoagulants. (It is acceptable if there is an appropriate withdrawal period)
5.Patients judged to be inappropriate by the attending physician.
6.Patients who have participated in this study.
100
1st name | Koichi |
Middle name | |
Last name | Goto |
National Cancer Center Hospital East
Depertment of Thoracic Oncology
277-8577
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
0471331111
kgoto@east.ncc.go.jp
1st name | Tetsuya |
Middle name | |
Last name | Sakai |
National Cancer Center Hospital East
Depertment of Thoracic Oncology
277-8577
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
0471331111
tetsakai@east.ncc.go.jp
National Cancer Center Hospital East
Depertment of Thoracic Oncology
National Cancer Center Hospital East
Depertment of Thoracic Oncology
Self funding
National Cancer Center Hospital East Certified Review Board
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
04-7133-1111
ncche-irb@east.ncc.go.jp
NO
2019 | Year | 05 | Month | 08 | Day |
Unpublished
Open public recruiting
2018 | Year | 06 | Month | 01 | Day |
2018 | Year | 06 | Month | 01 | Day |
2018 | Year | 11 | Month | 08 | Day |
2020 | Year | 02 | Month | 29 | Day |
2019 | Year | 05 | Month | 08 | Day |
2020 | Year | 05 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041787
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |