Robotic-Assisted Versus Conventional Bronchoscopy for Cryobiopsy in the Diagnosis of Interstitial Lung Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robotic-Assisted Bronchoscopy With Cone-Beam CT Guidance, Conventional Bronchoscopy With Fluoroscopy Guidance.
- Who it may be relevant to
- Registry conditions: Interstitial Lung Disease (ILD), Lung Biopsy. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Robotic-Assisted Versus Conventional Bronchoscopy for Cryobiopsy in the Diagnosis of Interstitial Lung Disease: A Randomized Controlled Trial
Overview
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.
Detailed description
Histopathologic evaluation remains a key component in the diagnosis of many interstitial lung diseases when radiological and clinical findings are inconclusive. Transbronchial lung cryobiopsy (TBLC) has increasingly replaced surgical lung biopsy due to its lower morbidity, but diagnostic yield varies widely depending on procedural technique and sampling accuracy.
Robotic-assisted bronchoscopy (RAB) offers improved catheter stability and precise navigation to peripheral lung regions. When combined with cone-beam CT (CBCT), RAB allows real-time confirmation of biopsy location, potentially improving sampling of diagnostically relevant lung parenchyma while avoiding bronchial structures.
However, the incremental diagnostic value of RAB combined with CBCT compared with conventional bronchoscopy using fluoroscopy guidance has not yet been evaluated in a randomized controlled trial.
This investigator-initiated trial aims to determine whether robotic-assisted bronchoscopy with CBCT improves the rate of definitive histological diagnosis compared with conventional bronchoscopy.
Participants will be randomized 1:1 to either:
* Conventional bronchoscopy with fluoroscopy-guided cryobiopsy * Robotic-assisted bronchoscopy with CBCT-guided cryobiopsy
In both arms, four biopsies will be obtained from two different lung lobes using a 1.7 mm cryoprobe.
Histological specimens will be evaluated by a blinded multidisciplinary ILD board.
Interventions
- Procedure Robotic-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. - Procedure Conventional 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.
Primary outcome measures
- Histological Diagnosis [Time frame: Perioperative/Periprocedural]
Secondary outcome measures (3)
- Biopsy Size [Time frame: Perioperative/Periprocedural]
- Tissue Composition of Biopsies [Time frame: Perioperative/Periprocedural]
- Safety Composite [Time frame: Up to 24 hours post procedure]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Switzerland · 2 centers
- Cantonal Hospital of Lucerne — Lucerne
- University Hospital Zurich — Zurich
Identifiers
NCT: NCT07500818 · BASEC Nr. 2024-00684 Trial B