Perioperative Outcome of Robotic Approach Versus Manual Videothoracoscopic Major Resection in Patients Affected by Early Lung Cancer: Results of a Randomized Multicentric Study (ROMAN Study)

Giulia Veronesi; Abbas El-Sayed Abbas; Piergiorgio Muriana; Rosalba Lembo; Edoardo Bottoni; Gianluca Perroni; Alberto Testori; Elisa Dieci; Charles T Bakhos; Shamus Car; Luca Luzzi; Marco Alloisio; Pierluigi Novellis

doi:10.3389/fonc.2021.726408

Perioperative Outcome of Robotic Approach Versus Manual Videothoracoscopic Major Resection in Patients Affected by Early Lung Cancer: Results of a Randomized Multicentric Study (ROMAN Study)

Front Oncol. 2021 Sep 9:11:726408. doi: 10.3389/fonc.2021.726408. eCollection 2021.

Authors

Giulia Veronesi^{1

2}, Abbas El-Sayed Abbas^{3

4}, Piergiorgio Muriana¹, Rosalba Lembo⁵, Edoardo Bottoni⁶, Gianluca Perroni¹, Alberto Testori⁶, Elisa Dieci¹, Charles T Bakhos^{3

4}, Shamus Car⁷, Luca Luzzi⁸, Marco Alloisio^{6

9}, Pierluigi Novellis¹

Affiliations

¹ Department of Thoracic Surgery, IRCCS San Raffaele Scientific Institute, Milan, Italy.
² Faculty of Medicine and Surgery, Vita-Salute San Raffaele University, Milan, Italy.
³ Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University Hospital, Philadelphia, PA, United States.
⁴ Department of Surgery, Lewis Katz School of Medicine, Temple University Hospital, Philadelphia, PA, United States.
⁵ Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.
⁶ Division of Thoracic and General Surgery, Humanitas Clinical and Research Center, Rozzano, Italy.
⁷ Division of Thoracic Surgery, Department of Surgery, University of Maryland School of Medicine, Baltimore, MD, United States.
⁸ Thoracic Surgery Unit, Department of Medicine, Surgery and Neuro Sciences, Diagnostic Imaging, University of Siena, Azienda Ospedaliera Universitaria Senese, Siena, Italy.
⁹ Department of Biomedical Science, Humanitas University, Rozzano, Italy.

Abstract

Introduction: We report the results of the first prospective international randomized control trial to compare the perioperative outcome and surgical radicality of the robotic approach with those of traditional video-assisted surgery in the treatment of early-stage lung cancer.

Methods: Patients with clinical stage T1-T2, N0-N1 non-small cell lung cancer (NSCLC) were randomly assigned to robotic-assisted thoracoscopic surgery (RATS) or video-assisted thoracic surgery (VATS) resection arms. The primary objective was the incidence of adverse events including complications and conversion to thoracotomy. The secondary objectives included extent of lymph node (LN) dissection and other indicators.

Results: This trial was closed at 83 cases as the probability of concluding in favor of the robot arm for the primary outcome was null according to the observed trend. In this study, we report the results of the analysis conducted on the patients enrolled until trial suspension. Thirty-nine cases were randomized in the VATS arm and 38 in the robotic arm. Six patients were excluded from analysis. Despite finding no difference between the two arms in perioperative complications, conversions, duration of surgery, or duration of postoperative stay, a significantly greater degree of LN assessment by the robotic technique was observed in regards to the median number of sampled LN stations [6, interquartile range (IQR) 4-6 vs. 4, IQR 3-5; p = 0.0002], hilar LNs (7, IQR 5-10 vs. 4, IQR 2-7; p = 0.0003), and mediastinal LNs (7, IQR 5-10 vs. 5, IQR 3-7; p = 0.0001).

Conclusions: The results of this trial demonstrated that RATS was not superior to VATS considering the perioperative outcome for early-stage NSCLC, but the robotic approach allowed an improvement of LN dissection. Further studies are suggested to validate the results of this trial.

Clinical trial registration: clinicaltrials.gov, identifier NCT02804893.

Keywords: VATS; non-small cell lung cancer (NSCLC); randomized study; robotic surgery; surgery.

Associated data

ClinicalTrials.gov/NCT02804893