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GGO-dominant PPLs Diagnosis Using CLE and ssRAB-guided Cryobiopsy
Sponsor: Shanghai Chest Hospital
Summary
The purpose of the study is to evaluate the diagnostic performance and safety of cryobiopsy for ground-glass opacity (GGO)-dominant peripheral pulmonary lesions (PPLs) under the guidance of shape-sensing robotic-assisted bronchoscopy (ssRAB) combined with confocal laser endomicroscopy (CLE). Additionally, the study aims to establish CLE interpretation criteria for GGO-dominant PPLs based on histopathological characteristics and validate the proposed criteria.
Official title: Ground-glass Opacity-dominant Peripheral Pulmonary Lesions Diagnosis Using Confocal Laser Endomicroscopy and Shape-sensing Robotic-assisted Bronchoscopy Guided Cryobiopsy: GLASS-CLEAR Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
119
Start Date
2025-04
Completion Date
2027-04
Last Updated
2025-04-06
Healthy Volunteers
No
Conditions
Interventions
CLE and ssRAB-guided cryobiopsy
All procedures are performed under general anesthesia with endotracheal intubation and mechanical ventilation. A conventional flexible bronchoscope is used to examine the subject's airway and clear the secretion. After the registration procedure is completed, the catheter of the ssRAB system is navigated to the target lesion. Cone beam computed tomography (CBCT) is used to confirm whether the target lesion has been reached. After that, an appropriate CLE probe is inserted. Right before CLE imaging, 2.5 ml of 10% fluorescein sodium is administered intravenously. CLE is then used to examine the target lesion. Based on real-time CLE imaging, the optimal biopsy location is identified and localized on the fluoroscopy. After CLE imaging, the CLE probe is retracted, followed by cryobiopsy at the same location under fluoroscopy guidance. Rapid on-site evaluation is available during the procedure to assess sample adequacy.
Locations (1)
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China