Robotic-assisted versus conventional bronchoscopy for cryobiopsy to diagnose interstitial lung disease
Robotic-Assisted Versus Conventional Bronchoscopy for Cryobiopsy in the Diagnosis of Interstitial Lung Disease: A Randomized Controlled Trial
This trial will test whether robotic-assisted bronchoscopy with cone-beam CT finds better biopsy samples than conventional fluoroscopy-guided bronchoscopy in adults who need a lung biopsy for suspected interstitial lung disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 2 sites (Lucerne, Canton of Lucerne and 1 other locations) |
| Trial ID | NCT07500818 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized trial assigns patients 1:1 to either conventional bronchoscopy with fluoroscopy-guided transbronchial lung cryobiopsy or robotic-assisted bronchoscopy with cone-beam CT guidance. In both arms four biopsies will be taken from two different lobes using a 1.7 mm cryoprobe. Biopsy location with RAB+CBCT allows real-time confirmation of sampling, while the conventional arm relies on 2D fluoroscopy for navigation. Histological specimens will be reviewed by a blinded multidisciplinary ILD board to determine diagnostic yield.
Who should consider this trial
Good fit: Adults (age ≥18) with suspected interstitial lung disease who have a non-diagnostic or indeterminate HRCT pattern and are medically eligible for transbronchial lung cryobiopsy are ideal candidates.
Not a fit: Patients with a definite UIP pattern on HRCT, severe pulmonary hypertension, severe hypoxemia, coagulopathy, pregnancy, or other contraindications to bronchoscopy are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, robotic-assisted bronchoscopy with CBCT could increase the rate of definitive histologic diagnoses and reduce the need for surgical lung biopsy.
How similar studies have performed: Observational and feasibility studies suggest improved navigation and sampling with robotic bronchoscopy and CBCT, but randomized controlled data directly comparing this approach to fluoroscopy-guided cryobiopsy are not yet available.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Definite UIP pattern on HRCT * Severe pulmonary hypertension * Severe hypoxemia contraindicating bronchoscopy * Coagulopathy or contraindication to biopsy * Pregnancy * Inability to provide informed consent
Where this trial is running
Lucerne, Canton of Lucerne and 1 other locations
- Cantonal Hospital of Lucerne — Lucerne, Canton of Lucerne, Switzerland (Recruiting)
- University Hospital Zurich — Zurich, Canton of Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Thomas Gaisl, MD MPH PhD
- Email: thomas.gaisl@uzh.ch
- Phone: +41762318339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.