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The prospective randomized controlled trial of endbronchial ultrasound-guided transbronchial needle aspiration using 22G and 25G aspiration needles for lung cancer

The prospective randomized controlled trial of endbronchial ultrasound-guided transbronchial needle aspiration using 22G and 25G aspiration needles for lung cancer - TBNA needle study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000036680
Enrollment
100
Registered
2019-05-08
Start date
2018-11-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

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

Sponsors

National Cancer Center Hospital East Depertment of Thoracic Oncology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactTetsuya Sakai

National Cancer Center Hospital East Depertment of Thoracic Oncology

tetsakai@east.ncc.go.jp0471331111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026