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

Not Applicable

Not yet recruiting

• Conditions: Solitary Pulmonary Nodule; Multiple Pulmonary Nodule

• Registration Number: NCT06741826
• Lead Sponsor: China-Japan Friendship Hospital

Brief 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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Study Start: 2025-01-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

• Patients with peripheral pulmonary nodules suspected of lung cancer by CT examination
• Patients who intend to undergo a bronchoscopic lung biopsy to determine benign or malignant pulmonary nodules;
• Age ≥18 years
• Sign informed consent.

Exclusion Criteria

• There is an uncorrectable coagulation disorder or anticoagulation therapy that cannot be stopped before surgery;
• Tumors can be seen in the bronchus
• Hemodynamic instability;
• Refractory hypoxemia;
• Patients with pregnant and lactating patients
• Any illness or condition that interferes with the completion of the initial or subsequent assessment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diagnostic rate of biopsy to obtain pathological diagnosis.	6 months	The biopsies obtained from the two groups were fixed in 10% formaldehyde and sent for pathological examination. The pathological diagnosis results were identified by two pathologists back to back, and the results were consistent, that is, confirmed. If the results are inconsistent, they will be identified by a third pathologist and finally determined by the three experts after discussion.

Secondary Outcome Measures

Name	Time	Method
Occurrence of operation-related complications	6 months	7 days of follow-up data (including bleeding, infection, pain, fever, etc.). Patients who did not obtain a confirmed diagnosis were followed up to 6 months after surgery to evaluate their diagnosis.