Interstitial Lung Disease (ILD)
Conditions
Keywords
probe-based confocal laser endomicroscopy, pCLE, transbronchial lung cryobiopsy, TBLC, interstitial lung disease, ILD
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREpCLE-guided transbronchial lung cryobiopsy
Probe-based confocal laser endomicroscopy is used before TBLC to assist biopsy-site selection within the predefined target region.
PROCEDUREFluoroscopy-guided transbronchial lung cryobiopsy
TBLC is performed at biopsy sites selected according to conventional clinical and radiological assessment without pCLE guidance.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria： 1. adults with suspected interstitial lung disease (ILD). 2. Clinical and HRCT findings insufficient to establish a definitive diagnosis. 3. Histopathological evaluation by TBLC considered necessary after multidisciplinary discussion. 4. Age ≥18 years 5. Written informed consent provided.
Exclusion criteria
1. Contraindications to bronchoscopy or TBLC. 2. Severe hypoxemia or uncontrolled bleeding risk. 3. Severe pulmonary hypertension or unstable cardiopulmonary disease. 4. Active infection. 5. Pregnancy. 6. Inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MDD diagnostic yield after TBLC | 6 months | MDD diagnostic yield after TBLC, defined as the proportion of participants with a specific final diagnosis established by post-biopsy MDD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of operation-related complications | 6 months | Final diagnostic categories, biopsy specimen characteristics, bleeding severity and volume, hemostatic interventions, pneumothorax, and mortality within 7 days after TBLC. |
Countries
China
Outcome results
None listed