title: Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial.
abstract: OBJECTIVE
  To facilitate localization and resection of small lung nodules, we developed a prospective clinical trial (ClinicalTrials.gov number NCT01847209) for a novel surgical approach which combines placement of fiducials using intra-operative C-arm computed tomography (CT) guidance with standard thoracoscopic resection technique using image-guided video-assisted thoracoscopic surgery (iVATS).
  
  
  METHODS
  Pretrial training was performed in a porcine model using C-arm CT and needle guidance software. Methodology and workflow for iVATS was developed, and a multi-modality team was trained. A prospective phase I-II clinical trial was initiated with the goal of recruiting eligible patients with small peripheral pulmonary nodules. Intra-operative C-arm CT scan was utilized for guidance of percutaneous marking with two T-bars (Kimberly-Clark, Roswell, GA) followed by VATS resection of the tumor.
  
  
  RESULTS
  Twenty-five patients were enrolled; 23 underwent iVATS, one withdrew, and one lesion resolved. Size of lesions were: 0.6-1.8 cm, mean = 1.3 ± 0.38 cm.. All 23 patients underwent complete resection of their lesions. CT imaging of the resected specimens confirmed the removal of the T-bars and the nodule. Average and total procedure radiation dose was in the acceptable low range (median = 1501 μGy*m(2), range 665-16,326). There were no deaths, and all patients were discharged from the hospital (median length of stay = 4 days, range 2-12). Three patients had postoperative complications: one prolonged air-leak, one pneumonia, and one ileus.
  
  
  CONCLUSIONS
  A successful and safe step-wise process has been established for iVATS, combining intra-operative C-arm CT scanning and thoracoscopic surgery in a hybrid operating room.
authors.affiliation: Department of Radiology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Ritu R
authors.initials: RR
authors.lastname: Gill
authors.affiliation: Division of Thoracic Surgery, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Yifan
authors.initials: Y
authors.lastname: Zheng
authors.affiliation: Division of Thoracic Surgery, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Julianne S
authors.initials: JS
authors.lastname: Barlow
authors.affiliation: Department of Radiology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Jagadeesan
authors.initials: J
authors.lastname: Jayender
authors.affiliation: Siemens Corporation, Corporate Technology, Princeton, New Jersey.
authors.forename: Erin E
authors.initials: EE
authors.lastname: Girard
authors.affiliation: Department of Anaesthesia, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Philip M
authors.initials: PM
authors.lastname: Hartigan
authors.affiliation: Department of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Lucian R
authors.initials: LR
authors.lastname: Chirieac
authors.affiliation: Division of Thoracic Surgery, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Carol J
authors.initials: CJ
authors.lastname: Belle-King
authors.affiliation: Division of Thoracic Surgery, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Kristen
authors.initials: K
authors.lastname: Murray
authors.affiliation: Division of Thoracic Surgery, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Christopher
authors.initials: C
authors.lastname: Sears
authors.affiliation: Division of Thoracic Surgery, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Jon O
authors.initials: JO
authors.lastname: Wee
authors.affiliation: Division of Thoracic Surgery, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Michael T
authors.initials: MT
authors.lastname: Jaklitsch
authors.affiliation: Division of Thoracic Surgery, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Yolonda L
authors.initials: YL
authors.lastname: Colson
authors.affiliation: Division of Thoracic Surgery, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Raphael
authors.initials: R
authors.lastname: Bueno
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007430:Intraoperative Care; D008175:Lung Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D055613:Multiple Pulmonary Nodules / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D009367:Neoplasm Staging; D011013:Pneumonectomy; D011183:Postoperative Complications; D011379:Prognosis; D011446:Prospective Studies; D015641:Radiography, Interventional; D003074:Solitary Pulmonary Nodule / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D025321:Surgery, Computer-Assisted / Q000379:methods*; D020775:Thoracic Surgery, Video-Assisted / Q000379:methods*; D014057:Tomography, X-Ray Computed / Q000379:methods*; D055815:Young Adult
keywords: C-arm CT; VATS; advanced image guided operating room; fiducials; hybrid operating room; lung cancer