UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060663 |
|---|---|
| Receipt number | R000069310 |
| Scientific Title | Efficacy of a thin convex-probe endobronchial ultrasound bronchoscope in diagnosing pulmonary lesions across different lung regions: a randomized controlled trial |
| Date of disclosure of the study information | 2026/02/13 |
| Last modified on | 2026/02/16 08:48:28 |
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Basic information
Public title
A randomized controlled trial evaluating the utility of a thin convex-probe endobronchial ultrasound bronchoscope for the diagnosis of pulmonary lesions
Acronym
DAEDALUS-TCP
Scientific Title
Efficacy of a thin convex-probe endobronchial ultrasound bronchoscope in diagnosing pulmonary lesions across different lung regions: a randomized controlled trial
Scientific Title:Acronym
DAEDALUS-TCP (Diagnostic Advantage of Enhanced Distal Access Lung UltraSound: a randomized controlled trial using a Thin Convex-Probe bronchoscope)
Region
| Japan |
Condition
Condition
Pulmonary lesions (including benign and malignant lesions)
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic yield of the target pulmonary lesion
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Matsumoto |
Organization
National Cancer Center Hospital
Division name
Department of Endoscopy, Respiartory Endoscopy Division/Department of Thoracic Oncology
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku
TEL
+81335422511
yumatsum@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Matsumoto |
Organization
National Cancer Center Hospital
Division name
Department of Endoscopy, Respiartory Endoscopy Division/Department of Thoracic Oncology
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku
TEL
+81335422511
Homepage URL
yumatsum@ncc.go.jp
Sponsor or person
Institute
National Cancer Center, Japan
Institute
Department
Personal name
Yuji Matsumoto
Funding Source
Organization
National Cancer Center, Japan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku
Tel
+81335422511
ncch-irb@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立がん研究センター中央病院（東京都）、大阪公立大学大学院（大阪府）、北海道大学病院（北海道）、千葉大学医学部附属病院（千葉県）、宮崎県立宮崎病院（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 12 | Day |
Last modified on
| 2026 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069310
