Status:
NOT_YET_RECRUITING
Novel Thin Bronchoscope Versus Ultrathin Bronchoscope for the Diagnosis of Peripheral Pulmonary Nodules
Lead Sponsor:
Shanghai Chest Hospital
Conditions:
Lung Cancer (Diagnosis)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, randomised, non-inferior, multicenter study in consecutive patients with solid or sub-solid PPLs 8 to 30 mm in diameter.The subjects will be randomly assigned in a 1:1:1 ratio t...
Detailed Description
This is a prospective, randomised, non-inferior, multicenter study. The inclusion criteria are patients whose chest imaging shows suspiciously malignant peripheral lung nodules (the nodules are surrou...
Eligibility Criteria
Inclusion
- Patients older than 18 years old.
- Chest imaging shows the presence of peripheral pulmonary lesions (defined as those lesions that are surrounded by pulmonary parenchyma and located below the segmental bronchus) that need to be confirmed by pathology. The length diameter of the lesion is no less than 8 mm and no more than 30mm.
- Patients without contraindications of bronchoscopy.
- Patients have good medical adherence and signed informed consent.
Exclusion
- Peripheral pulmonary lesion is pure ground-glass opacity.
- Visible lumen lesions in segment and above segment bronchus during bronchoscopy (evidence of endobronchial lesion, extrinsic compression, submucosal tumor, narrowing, inflammation or bleeding of the bronchus).
- The target lesion has been treated.
- Diffuse pulmonary lesions.
- The investigators believe that patient has other conditions that are not suitable for the study.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
465 Patients enrolled
Trial Details
Trial ID
NCT07135297
Start Date
September 1 2025
End Date
August 31 2026
Last Update
August 22 2025
Active Locations (5)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
2
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
3
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China, 210009
4
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315020