NCT Number: NCT07500818
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.
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Interventional
Not applicable
Cantonal Hospital of Lucerne, Lucerne, Canton of Lucerne, Switzerland
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Perioperative/Periprocedural
Rate of Definitive Histological Diagnosis
Time frame: Perioperative/Periprocedural
Mean cross-sectional area of cryobiopsy specimens measured in mm².
Time frame: Perioperative/Periprocedural
Percentage composition of biopsy specimens including:
Time frame: Up to 24 hours post procedure
Composite safety endpoint including:
Time frame: Perioperative/Periprocedural
Total radiation dose measured as dose-length product (DLP) or equivalent fluoroscopy dose.
Time frame: Perioperative/Periprocedural
Total procedure time measured from bronchoscope insertion to bronchoscope removal.
Contact information is provided by the study sponsor or research team.
University of Zurich
Other
Robotic-Assisted Versus Conventional Bronchoscopy for Cryobiopsy in the Diagnosis of Interstitial Lung Disease: A Randomized Controlled Trial
Acronym: RAB-ILD-RCT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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