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
Qualifiers
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
Treatments tested in this trial
- Robotic-Assisted Bronchoscopy With Cone-Beam CT Guidance
- Conventional Bronchoscopy With Fluoroscopy Guidance
Treatment groups
Sponsors and collaborators
University of Zurich
Lead sponsor
Cantonal Hospital of Lucerne, Switzerland
Collaborator
University Hospital, Zürich
Collaborator