ARTICULAtE
A Randomized Controlled Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB (ARTICULAtE)
Paziente / Popolazione Intervento / Esposizione Confronto Esito
In 264 patients with peripheral pulmonary nodules of 8 to 30 mm, shape-sensing robotic-assisted bronchoscopy improved diagnostic yield at the index procedure compared with electromagnetic navigation bronchoscopy.
Disegno
Multicentre, open-label, superiority randomised trial at three Chinese centres, sponsored by Intuitive Surgical, pathologist blinded to allocation; after a 90-patient non-randomised lead-in on the robotic system, adults with peripheral pulmonary nodules of 8 to 30 mm at or beyond subsegmental bronchi were randomised 1:1, stratified by nodule size, CT bronchus sign and location, to shape-sensing robotic-assisted bronchoscopy (Ion Endoluminal System) or electromagnetic navigation bronchoscopy (superDimension), both with radial endobronchial ultrasound and fluoroscopy under general anaesthesia; powered for a 15% absolute margin
Esito
Diagnostic yield at the index procedure (ATS/ACCP definition)
RisultatoDiagnostic yield 91.4% (95% CI 85.3-95.1) vs 65.2% (95% CI 56.7-72.7), absolute difference 26.3 percentage points (P < 0.0001), in 128 vs 132 of 264 randomised patients who underwent the procedure. Nodules of 20 mm or smaller 88.3% vs 53.2%, no CT bronchus sign 86.5% vs 50.0%, outer-third lesions 90.8% vs 66.2%. Safety comparable.
Xie F, Li C, Liu D, et al. Presented at ERS Congress 2026, ALERT 1, 6 September. Not yet published.
Discussione e critica
The first multicentre randomised comparison of robotic against electromagnetic navigation bronchoscopy, and the gap is large: 26 points on diagnostic yield, widest in the two subgroups where navigation bronchoscopy has always struggled, nodules of 20 mm or smaller and nodules without a CT bronchus sign. The control arm's 65% under the strict ATS/ACCP definition sits on the pooled 65% of the electromagnetic navigation literature, so the comparison is fair rather than flattering. Three Chinese centres, open-label, sponsored by the robot's maker, with a 90-patient lead-in on the device before randomisation began. A yield result: whether the extra diagnoses were right, and what they changed, is not yet reported.