To investigate the safety and efficacy of ultrafine cryoprobe biopsy by electromagnetic navigation bronchoscopy compared with biopsy forceps in the diagnosis of peripheral pulmonary nodules in a national multicenter randomized controlled trial
This project intends to carry out a national multicenter randomized controlled study, with traditional forceps biopsy as the control group and cryobiopsy as the experimental group, to verify the feasibility, effectiveness and safety of electromagnetic navigation bronchoscope-guided cryobiopsy in the diagnosis of peripheral pulmonary nodules, so as to provide an efficient and minimally invasive diagnostic method for the diagnosis of peripheral pulmonary nodules
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
228
Cryobiopsy : Insert a 1.1mm cryoprobe along the electromagnetic navigation catheter, obtain samples with at least 2 pieces each.
Forceps biopsy:Insert 1.8mm forceps along the electromagnetic navigation catheter, obtain at least five tissue samples through precise clamping.
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, China
Diagnostic yield
The primary outcome was the diagnostic yield of ENB-guided cryobiopsy and forceps biopsy for diagnosing pulmonary lesions
Time frame: follow-up for 12 months
Adverse events
Adverse events related to the research
Time frame: follow-up for one month
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