Confocal Laser Endomicroscopy Guided Cryobiopsy in the Diagnosis of Interstitial Lung Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina-Japan Friendship Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Navigation bronchoscopy combined with radial endobronchial ultrasound guided pulmonary nodule biopsy under needle-based confocal laser endomicroscopy.
Procedure/SurgeryNavigation bronchoscopy combined with radial endobronchial ultrasound guided pulmonary nodule biopsy under needle-based confocal laser endomicroscopy.
Treatment groups
530 Participants
are divided into 2 treatment groupsGroup A: Group nCLE-NB-rEBUSExperimental treatment 1 intervention
Group B: Group NB-rEBUSExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
6 monthsSecondary outcomes
1
Occurrence of operation-related complications
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.
Time frame
6 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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