Assessing the usefulness of the francine needle in EBUS-TBNA

JRCT ID: jRCT1032220388

Registered date:18/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Lung cancer
• Date of first enrollment: 18/10/2022
• Target sample size: 12
• Study type: Interventional

Intervention(s)

Patients are received EBUS-TBNA or TBNB using these devices under randomised:
A: Francine needle - Lancet needle
B: Lancet needle - Francine needle

Outcome(s)

• Primary Outcome: Tissue area of each lymph node sample

Secondary Outcome

Tumor percentage of each lymph node
Rate of blood contamination in each lymph node
Diagnostic concordance between Francine and Lancet needles
Adverse events
Success rate for biomarker test for each lymph node

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients with suspected primary lung cancer
2)Patients who are scheduled for endobronchial ultrasound-guided transbronchial needle aspiration or biopsy
3)Patients who are 20 years of age or older
4)Patients who are provided written informed consent

Exclude criteria

1)Patients who have a history of treatment for lung cancer
2)Patients for whom bronchoscopy is contraindicated
3)Patients who are pregnant, within 28 days postpartum, or lactating
4)Patients who are judged by the investigator to be unsuitable for this study

Related Information

• Primary Sponsor: Ikari Jun
• Source(s) of Monetary Support: Clinical Research Initiation - Fund of Chiba University Hospital