Robotic-Assisted Versus Conventional Bronchoscopy for Cryobiopsy in the Diagnosis of Interstitial Lung Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Zurich

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Robotic-Assisted Bronchoscopy With Cone-Beam CT Guidance

    Procedure/Surgery

    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.

  • Conventional Bronchoscopy With Fluoroscopy Guidance

    Procedure/Surgery

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Robotic-Assisted Bronchoscopy With Cone-Beam CT GuidanceExperimental treatment 1 intervention
Group B: Conventional Bronchoscopy With Fluoroscopy GuidanceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Histological Diagnosis

Rate of Definitive Histological Diagnosis

Time frame
Perioperative/Periprocedural

Secondary outcomes

1

Biopsy Size

Mean cross-sectional area of cryobiopsy specimens measured in mm².

Time frame
Perioperative/Periprocedural
2

Tissue Composition of Biopsies

Percentage composition of biopsy specimens including: * Lung parenchyma * Bronchial tissue * Bronchiolar tissue

Time frame
Perioperative/Periprocedural
3

Safety Composite

Composite safety endpoint including: * Clinically significant bleeding * Pneumothorax requiring intervention * Transfer to intensive care unit

Time frame
Up to 24 hours post procedure

Other outcomes

1

Radiation Exposure

Total radiation dose measured as dose-length product (DLP) or equivalent fluoroscopy dose.

Time frame
Perioperative/Periprocedural
2

Procedure Duration

Total procedure time measured from bronchoscope insertion to bronchoscope removal.

Time frame
Perioperative/Periprocedural

Sponsors and contacts

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University of Zurich

Lead sponsor

Cantonal Hospital of Lucerne, Switzerland

Collaborator

University Hospital, Zürich

Collaborator