About this trial
Interstitial lung disease (ILD) often requires histopathological confirmation when high-resolution computed tomography (HRCT) findings are inconclusive. Transbronchial lung cryobiopsy has emerged as a less invasive alternative to surgical lung biopsy, but diagnostic yield remains variable and dependent on biopsy location and procedural precision.
Robotic-assisted bronchoscopy (RAB) combined with cone-beam computed tomography (CBCT) may allow more precise navigation to target lung segments and potentially improve biopsy quality and diagnostic yield.
This multi-center, investigator-initiated randomized controlled trial will compare conventional bronchoscopy with 2D fluoroscopy guidance versus robotic-assisted bronchoscopy with CBCT guidance for transbronchial lung cryobiopsy in patients undergoing diagnostic evaluation for suspected interstitial lung disease.
Participants will be randomized in a 1:1 ratio to undergo either conventional bronchoscopy or robotic-assisted bronchoscopy. In both groups, four cryobiopsies will be obtained from two lung lobes using a 1.7 mm cryoprobe (en-bloc removal for both study arms).
The primary endpoint is the rate of definitive histological diagnosis as determined by a blinded multidisciplinary ILD board.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Clinical suspicion of interstitial lung disease requiring histological confirmation
Non-diagnostic HRCT pattern (e.g. probable UIP or indeterminate pattern)
Candidate for transbronchial lung cryobiopsy
Disqualifiers
Definite UIP pattern on HRCT
Severe pulmonary hypertension
Severe hypoxemia contraindicating bronchoscopy
Coagulopathy or contraindication to biopsy
Trial design
Parallel
Treatments tested in this trial
Robotic-Assisted Bronchoscopy With Cone-Beam CT Guidance
Procedure/SurgeryRobotic-assisted bronchoscopy using a shape-sensing robotic platform with cone-beam CT confirmation of biopsy location. Four cryobiopsies will be obtained from two lung lobes using a 1.7 mm cryoprobe.
Conventional Bronchoscopy With Fluoroscopy Guidance
Procedure/SurgeryFlexible bronchoscopy with 2D fluoroscopy guidance. Four cryobiopsies will be obtained from two lung lobes using a 1.7 mm cryoprobe.
Treatment groups
Trial outcomes
Primary outcomes
Histological Diagnosis
Rate of Definitive Histological Diagnosis
Secondary outcomes
Biopsy Size
Mean cross-sectional area of cryobiopsy specimens measured in mm².
Tissue Composition of Biopsies
Percentage composition of biopsy specimens including: * Lung parenchyma * Bronchial tissue * Bronchiolar tissue
Safety Composite
Composite safety endpoint including: * Clinically significant bleeding * Pneumothorax requiring intervention * Transfer to intensive care unit
Other outcomes
Radiation Exposure
Total radiation dose measured as dose-length product (DLP) or equivalent fluoroscopy dose.
Procedure Duration
Total procedure time measured from bronchoscope insertion to bronchoscope removal.
Sponsors and contacts
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University of Zurich
Lead sponsor
Cantonal Hospital of Lucerne, Switzerland
Collaborator
University Hospital, Zürich
Collaborator