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

Patients with suspected ILD undergo multidisciplinary evaluation before enrollment and are included when clinical and HRCT findings are insufficient for a definitive diagnosis and histopathological assessment by TBLC is considered necessary. Participants are randomized 1:1 to pCLE-guided TBLC or conventional TBLC. In both groups, biopsy targets are selected according to HRCT and multidisciplinary assessment, and TBLC is performed following established recommendations. In the pCLE-guided group, pCLE is additionally used within the predefined target area before biopsy to assist selection of suitable sampling sites. Histopathological assessment is performed by blinded pulmonary pathologists, and final diagnoses are established through post-biopsy multidisciplinary discussion integrating clinical, radiological, bronchoscopic, and pathological information.

Eligibility Criteria：

• adults with suspected interstitial lung disease (ILD).
• Clinical and HRCT findings insufficient to establish a definitive diagnosis.
• Histopathological evaluation by TBLC considered necessary after multidisciplinary discussion.
• Age ≥18 years
• Written informed consent provided.

Exclusion criteria

• Contraindications to bronchoscopy or TBLC.
• Severe hypoxemia or uncontrolled bleeding risk.
• Severe pulmonary hypertension or unstable cardiopulmonary disease.
• Active infection.
• Pregnancy.
• Inability to provide informed consent.