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

StatusCompleted
PhaseNot applicable
Started2025-12-03
View on ClinicalTrials.gov ↗

Amendment history

2026-09-03
Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Completed without a posted recruiting period
Primary endpoint(s) modified1 entry, revised
WasDiagnostic rate of biopsy to obtain pathological diagnosis.
NowMDD diagnostic yield after TBLC
Final enrollment: 430 participants (planned 530)
Primary completion confirmed: July 2026 (last estimated December 2026)
Interventions modified
Primary completion dateestimated 2026-12-31→confirmed 2026-07-20
Completion dateestimated 2026-12-31→confirmed 2026-07-27
Start dateestimated 2025-01-01→confirmed 2025-12-03
Enrollment targetestimated 530→confirmed 430
Study sites0→1
Eligibility criteria-74 characters
InclusionEligibility Criteria:： Patientsadults with peripheral pulmonary nodules suspected ofinterstitial lung cancerdisease (ILD). Clinical and HRCT findings insufficient to establish a definitive diagnosis. Histopathological evaluation by CTTBLC examinationconsidered necessary after multidisciplinary discussion. Patients who intend to undergo a bronchoscopic lung biopsy to determine benign or malignant pulmonary nodules; Age ≥18 years SignWritten informed consent provided. Exclusion Criteria: ThereContraindications isto an uncorrectable coagulation disorderbronchoscopy or anticoagulation the [...] [...]
Secondary endpointsdetails revised at 1 of 1 entry
Study description-170 characters
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 ofILD lungundergo cancermultidisciplinary evaluation before enrollment and pulmonaryare tuberculosisincluded werewhen enrolledclinical toand signHRCT informedfindings consentare insufficient for a definitive diagnosis and histopathological assessment by TBLC is considered necessary. SubjectsParticipants wereare randomized to the nCLE-NB-rEBUS Group (Group A) or the NB [...] [...]
2024-12-16
Original filing
This prospective, single-center, randomized controlled trial compares pCLE-guided TBLC with conventional TBLC in patients with suspected interstitial lung disease. The study evaluates whether pCLE guidance improves diagnostic performance and procedural safety, with outcomes including final diagnosis and biopsy-related complications.
Trial Details
NCT Number NCT06741826
Lead Sponsor China-Japan Friendship Hospital
Conditions Interstitial Lung Disease (ILD)
Enrollment 430 participants
Start Date 2025-12-03
Primary Completion 2026-07-20 (estimated)
Study Completion 2026-07-27 (estimated)
Updated on ClinicalTrials.gov 2026-09-08