RecruitingNot ApplicableNCT07500818

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


Sponsor

University of Zurich

Enrollment

30 participants

Start Date

Feb 1, 2026

Study Type

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURERobotic-Assisted Bronchoscopy With Cone-Beam CT Guidance

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.

PROCEDUREConventional Bronchoscopy With Fluoroscopy Guidance

Flexible bronchoscopy with 2D fluoroscopy guidance. Four cryobiopsies will be obtained from two lung lobes using a 1.7 mm cryoprobe.


Locations(2)

Cantonal Hospital of Lucerne

Lucerne, Canton of Lucerne, Switzerland

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07500818


Related Trials