Abstract
IntroductionWe 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.MethodsPatients 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.ResultsThis 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).ConclusionsThe 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 Registrationclinicaltrials.gov, identifier NCT02804893.
Highlights
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
Six patients were excluded from randomization: in detail, three patients did not undergo surgery because of contraindications encountered during the preoperative evaluation and three patients for other reasons
In their systematic review of perioperative and oncological outcomes of patients undergoing surgical treatment of lung cancer, Azgarian and colleagues advocated the need of a prospective randomized trial to compare open surgery, video-assisted thoracoscopic surgery (VATS), and robotic-assisted thoracoscopic surgery (RATS) to overcome biased results introduced by selection [12]
Summary
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. Many studies have shown that robotic-assisted pulmonary resection is both feasible and safe for the treatment of lung cancer [1,2,3, 5,6,7], with longterm outcomes comparable to that reported for open and VATS approaches [8, 9]. Different results were shown in 2017 by Oh et al, who analyzed the Premier Healthcare Database to compare perioperative clinical outcomes from elective lobectomy by RATS, VATS, and thoracotomy, with propensity score matching (1:1). Compared with the VATS and open approaches, RATS lobectomy was associated with a shorter length of stay, lower complication rates, and lower conversion rate [10]
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