Tokyo, Feb. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060663) titled 'A randomized controlled trial evaluating the utility of a thin convex-probe endobronchial ultrasound bronchoscope for the diagnosis of pulmonary lesions' on Feb. 13.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - National Cancer Center, Japan

Condition: Condition - Pulmonary lesions (including benign and malignant lesions) Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate whether the use of a thin convex-probe endobronchial ultrasound bronchoscope improves the diagnostic yield for target pulmonary lesions compared with a standard convex-probe endobronchial ultrasound bronchoscope in patients undergoing bronchoscopic diagnosis of pulmonary lesions mainly located in the central and intermediate lung regions. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Bronchoscopic diagnosis of the target pulmonary lesion using a standard convex-probe endobronchial ultrasound bronchoscope (BF-UC290F). Systematic nodal staging will be performed as needed. Endobronchial ultrasound-guided transbronchial needle aspiration of the target pulmonary lesion will be performed when technically feasible. Interventions/Control_2 - Bronchoscopic diagnosis of the target pulmonary lesion using a thin convex-probe endobronchial ultrasound bronchoscope (BF-UCP190F). Systematic nodal staging will be performed as needed. Endobronchial ultrasound-guided transbronchial needle aspiration of the target pulmonary lesion will be performed when technically feasible.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients with a peripheral pulmonary lesion requiring definitive diagnosis who are scheduled for bronchoscopic diagnosis (excluding airway lesions and ill-defined infiltrative opacities). 2. Patients who underwent chest thin-section CT within 60 days before registration and whose target lesion meets the imaging criteria defined in the protocol. 3. Age 18 years or older at registration. 4. Written informed consent obtained from the patient. Key exclusion criteria - 1. History of local treatment (e.g., surgery or radiotherapy) for bronchial/lung lesions on the same side as the target lesion. 2. Target lesion predominantly ground-glass opacity (consolidation tumor ratio <0.5). 3. Strong suspicion of mediastinal lymph node metastasis on imaging (except as specified in the protocol). 4. Patients considered unable to safely undergo bronchoscopy due to uncontrolled comorbidities or severe bleeding tendency. 5. Patients receiving anticoagulants/antiplatelet agents that cannot be discontinued for the procedure (continuation of aspirin alone is permitted). 6. Patients deemed unsuitable for participation by the attending physician. Target Size - 140

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 12 Day Date of IRB - 2026 Year 01 Month 29 Day Anticipated trial start date - 2026 Year 02 Month 16 Day Last follow-up date - 2027 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069310

Disclaimer: Curated by HT Syndication.