Robotic-Assisted Versus Conventional Bronchoscopy for Cryobiopsy in the Diagnosis of Interstitial Lung Disease
Robotic-Assisted Versus Conventional Bronchoscopy for Cryobiopsy in the Diagnosis of Interstitial Lung Disease: A Randomized Controlled Trial
University of Zurich
30 participants
Feb 1, 2026
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria5
- 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
- Ability to provide informed consent
Exclusion Criteria6
- Definite UIP pattern on HRCT
- Severe pulmonary hypertension
- Severe hypoxemia contraindicating bronchoscopy
- Coagulopathy or contraindication to biopsy
- Pregnancy
- Inability to provide informed consent
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Interventions
Robotic-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.
Flexible bronchoscopy with 2D fluoroscopy guidance. Four cryobiopsies will be obtained from two lung lobes using a 1.7 mm cryoprobe.
Locations(2)
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NCT07500818