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

Overview

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.

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.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes