NCT06741826

Confocal Laser Endomicroscopy Guided Cryobiopsy in the Diagnosis of Interstitial Lung Disease

The Diagnostic Performance and Safety of Confocal Laser Endomicroscopy Guided Transbronchial Lung Cryobiopsy in the Diagnosis of Interstitial Lung Disease: a Randomised Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 530 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective multicenter randomized controlled trial was conducted to evaluate the diagnostic efficacy and safety of NCLE-NB-Rebus-guided peripheral pulmonary nodule biopsy, and to compare the diagnostic efficacy and safety of biopsy forceps biopsy and needle aspiration biopsy in peripheral pulmonary nodule biopsy guided by nCLE-NB-rEBUS.

Detailed description

A prospective, multicenter, randomized controlled trial was conducted to evaluate the diagnostic efficacy and safety of nCLE-NB-rEBUS guided peripheral pulmonary nodule biopsy. Patients with peripheral pulmonary nodules suspected of lung cancer and pulmonary tuberculosis were enrolled to sign informed consent. Subjects were randomized to the nCLE-NB-rEBUS Group (Group A) or the NB-rEBUS Group (Group B) subgroup (1:1 ratio) according to the random number table, and subjects randomly assigned to Group A or Group B were again randomized to the biopsy forceps subgroup or biopsy needle subgroup by the random number table. The diagnostic efficacy and safety of the NCLE-NB-REbus group and the NB-rEBUS group were compared to evaluate whether nCLE could improve the diagnostic rate of NB-REbus-guided peripheral pulmonary nodule biopsy. The diagnostic efficacy and safety of using biopsy forceps and biopsy needle in peripheral pulmonary nodule biopsy guided by nCLE-NB-rEBUS were compared to determine the reasonable biopsy method.

Conditions

• Solitary Pulmonary Nodule
• Multiple Pulmonary Nodule

Interventions

Type	Name	Description
PROCEDURE	Navigation bronchoscopy combined with radial endobronchial ultrasound guided pulmonary nodule biopsy under needle-based confocal laser endomicroscopy.	Navigation bronchoscopy combined with radial endobronchial ultrasound guided pulmonary nodule biopsy under needle-based confocal laser endomicroscopy.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-12-19
• Last updated: 2024-12-19