Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial.

Abstract

PurposeTo 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).MethodsPretrial 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.ResultsTwenty‐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*m2, 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.ConclusionsA 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. J. Surg. Oncol. 2015 111:18–25. © 2015 The Authors. Journal of Surgical Oncology Published by Wiley Periodicals, Inc.