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

NCT06741826 | Not Yet Recruiting

• 1 other identifier: 2022YFC2404404-1
• Study Type: interventional
• Target: 530
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodule

Outcome Measures

Primary Outcomes (1)

• Diagnostic rate of biopsy to obtain pathological diagnosis.

  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.

  6 months

Secondary Outcomes (1)

• Occurrence of operation-related complications

  6 months

Study Arms (2)

Group nCLE-NB-rEBUS

EXPERIMENTAL

According to the preoperative planning, the bronchoscope was placed at the bronchial opening of the target lobe segment, and the catheter was operated to reach the target lesion under the guidance of virtual navigation and after reaching the target lesion, the ultrasonic probe was opened to observe whether the ultrasonic image of the target lesion could be detected, and the image recording was collected to confirm that the virtual navigation catheter had accurately reached the target lesion. The ultrasound probe was removed, the TX ™ disposable transbronchoscopic dilator catheter was inserted to establish a working channel, and the nCLE was inserted to probe the benign and malignant status of the pleural lesion to determine the biopsy location and image recording was taken. Then the biopsy equipment was inserted and delivered to the target lesion for biopsy, and 5 pieces of biopsy tissue were collected.

Procedure: Navigation bronchoscopy combined with radial endobronchial ultrasound guided pulmonary nodule biopsy under needle-based confocal laser endomicroscopy.

Group NB-rEBUS

EXPERIMENTAL

After anesthesia, electronic bronchoscope was inserted through laryngeal mask/tracheal intubation for routine bronchoscopy. According to the preoperative planning, the bronchoscope was placed at the bronchial opening of the target lobe segment, and the catheter was operated to reach the target lesion under the guidance of virtual navigation, and was placed about 1 cm away from the target. The radial ultrasonic probe was implanted, and after reaching the target lesion, the ultrasonic probe was opened to observe whether the ultrasonic image of the target lesion could be detected, and the image recording was collected to confirm that the virtual navigation catheter had accurately reached the target lesion. Take out the ultrasonic probe, insert it into the biopsy equipment, deliver it to the target lesion for biopsy, and collect 5 pieces of biopsy tissue.

Procedure: Navigation bronchoscopy combined with radial endobronchial ultrasound guided pulmonary nodule biopsy under needle-based confocal laser endomicroscopy.

Interventions

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

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

Also known as: Navigation bronchoscopy combined with radial endobronchial ultrasound guided pulmonary nodule biopsy.

Group NB-rEBUS; Group nCLE-NB-rEBUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Gang Hou

CONTACT

13840065481; hougangcmu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share