A randomized controlled trial evaluating the utility of a thin convex-probe endobronchial ultrasound bronchoscope for the diagnosis of pulmonary lesions

Efficacy of a thin convex-probe endobronchial ultrasound bronchoscope in diagnosing pulmonary lesions across different lung regions: a randomized controlled trial - DAEDALUS-TCP (Diagnostic Advantage of Enhanced Distal Access Lung UltraSound: a randomized controlled trial using a Thin Convex-Probe bronchoscope)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060663

Enrollment

140

Registered

2026-02-13

Start date

2026-02-16

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

Pulmonary lesions (including benign and malignant lesions)

Interventions

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. Endobronch

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Diagnostic yield of the target pulmonary lesion	—

Secondary

Measure	Time frame
1. Diagnostic yield of the target pulmonary lesion by EBUS-TBNA 2. Mapping of target pulmonary lesions in terms of visibility and puncturability 3. Feasibility for nodal staging 4. Safety outcomes 5. Procedure time	—

Countries

Japan

Contacts

Public ContactYuji Matsumoto

National Cancer Center Hospital Department of Endoscopy, Respiartory Endoscopy Division/Department of Thoracic Oncology

yumatsum@ncc.go.jp+81335422511

Outcome results

None listed

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