{
  "abstract": "Background The use of 3D imaging with navigation bronchoscopy has increased with the introduction of mobile cone-beam CT (mCBCT). Shape-sensing robotic-assisted bronchoscopy (ssRAB) integrated with mCBCT has been introduced to correct for CT to body divergence (CT-BD) during the biopsy of peripheral pulmonary nodules (PPNs).Methods Prospective observational multicentre study, enrolling patients with a PPN of ≤20 mm suspicious for malignancy, assessing tool-in-lesion (TIL), diagnostic yield, sensitivity for malignancy and incidence of pneumothorax or airway bleeding. Non-malignant index biopsies were followed for 12 months. Descriptive statistics are reported for all variables along with 95% CI for primary endpoints.Results 155 consecutive patients were enrolled at six centres. Median nodule size was 14.0 mm (IQR 11.0–17.0), with 54.8% of nodules (85/155) in the upper lobes, 25.8% (40/155) with CT bronchus sign present and median distance to the nearest pleural surface of 8.2 mm (IQR 1.8–20.0). TIL was achieved in 154/155 (99.4%, 95% CI 96.5 to 100.0) procedures. A median of two (IQR 1–3) mCBCT spins were performed, with median dose area product of 25.7 Gy · cm 2 (IQR 11.0–46.7). Diagnostic yield per the American Thoracic Society/American College of Chest Physicians (ATC/ACCP) definition was 89.0% (n=138/155; 95% CI 83.0 to 93.5) and sensitivity for malignancy was 91.5% (95% CI 86.4 to 96.5). No pneumothorax (0%, 95% CI 0.0 to 2.4) and two Nashville Grade three bleeding events were reported (1.3%, 95% CI 0.2 to 4.6).Interpretation The first prospective multicentre study of integrated ssRAB and mCBCT for small peripheral nodules resulted in diagnostic outcomes similar to those reported for transthoracic biopsy with a more favourable safety profile.Trial registration number ClinicalTrials.gov ID: NCT05562895.",
  "authors": [
    {
      "affiliations": [
        "Pulmonary, Allergy and Sleep Medicine, Mayo Clinic in Florida, Jacksonville, Florida, USA"
      ],
      "name": "Bryan C Husta"
    },
    {
      "affiliations": [
        "Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, University of California San Diego, La Jolla, California, USA"
      ],
      "name": "George Z Cheng"
    },
    {
      "affiliations": [
        "Department of Critical Care Medicine, University of Alabama at Birmingham Health System Authority, Birmingham, Alabama, USA"
      ],
      "name": "Hitesh Batra"
    },
    {
      "affiliations": [
        "Thoracic Surgery, Mayo Clinic, Rochester, Minnesota, USA"
      ],
      "name": "Janani S Reisenauer"
    },
    {
      "affiliations": [
        "Pulmonary Medicine, St. David’s South Austin Medical Center, Austin, Texas, USA"
      ],
      "name": "William M Bartek"
    },
    {
      "affiliations": [
        "Pulmonary and Critical Care, Memorial Sloan Kettering Cancer Center, New York, New York, USA"
      ],
      "name": "Or Kalchiem-Dekel"
    },
    {
      "affiliations": [
        "Department of Critical Care Medicine, University of Alabama at Birmingham Health System Authority, Birmingham, Alabama, USA"
      ],
      "name": "Aline Zouk"
    },
    {
      "affiliations": [
        "University of California San Diego, La Jolla, California, USA"
      ],
      "name": "Niral Patel"
    },
    {
      "affiliations": [
        "Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA"
      ],
      "name": "Mohit Chawla"
    },
    {
      "affiliations": [
        "Pulmonary Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"
      ],
      "name": "George A Eapen"
    },
    {
      "affiliations": [
        "Pulmonary Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"
      ],
      "name": "Carlos A Jimenez"
    },
    {
      "affiliations": [
        "Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA",
        "Memorial Sloan Kettering Cancer Center, New York, New York, USA"
      ],
      "name": "Robert P Lee"
    },
    {
      "affiliations": [
        "Memorial Sloan Kettering Cancer Center, New York, New York, USA",
        "Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA"
      ],
      "name": "Matthew J Bott"
    },
    {
      "affiliations": [
        "Section of Interventional Pulmonology, Keck School of Medicine at USC, Los Angeles, California, USA"
      ],
      "name": "Scott Oh"
    },
    {
      "affiliations": [
        "Pulmonary Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA"
      ],
      "name": "Roberto F Casal"
    }
  ],
  "title": "Shape-sensing robotic-assisted bronchoscopy with integrated mobile cone-beam CT for small nodules: results from the prospective multicentre CONFIRM study",
  "uid": "7dacb01e-b18f-59a1-8fe3-ec1ac87de1e6"
}