Robotic-assisted versus video-assisted lobectomy for resectable non-small-cell lung cancer: the RVlob randomized controlled trial.

Background: The long-term survival and perioperative outcomes of robotic-assisted lobectomy (RAL) and video-assisted lobectomy (VAL) in resectable non-small-cell lung cancer (NSCLC) were found to be comparable in retrospective studies, but they have not been investigated in a randomized trial setting. We conducted the RVlob trial to investigate if RAL was non-inferior to VAL in patients with resectable NSCLC. Methods: In this single-center, open-label, and parallel-arm randomized controlled trial conducted in Ruijin Hospital (Shanghai, China) between May 2017 and May 2020, we randomly assigned patients with resectable NSCLC in a 1:1 ratio to receive either RAL or VAL. One of the primary endpoints was 3-year overall survival. Secondary endpoints included 3-year disease-free survival. The Kaplan-Meier approach was used to calculate overall survival and disease-free survival at 3 years. This study was registered with ClinicalTrials.gov, NCT03134534. Findings: A total of 320 patients were randomized to receive RAL (n = 157) or VAL (n = 163). The baseline characteristics of patients were well balanced between the two groups. After a median follow-up of 58.0 months, the 3-year overall survival was 94.6% (95% confidence interval [CI], 91.0-98.3) in the RAL group and 91.5% (95% CI, 87.2-96.0) in the VAL group (hazard ratio [HR] for death, 0.65; 95% CI, 0.33-1.28; P = 0.21); noninferiority of RAL was confirmed according to the predefined margin of -5% (absolute difference, 2.96%; a one-sided 90% CI, -1.39% to ∞; P = 0.0029 for noninferiority). The 3-year disease-free survival was 88.7% (95% CI, 83.6-94.1) in the RAL group and 85.4% (95% CI, 80.0-91.2) in the VAL group (HR for disease recurrence or death, 0.87; 95% CI, 0.50-1.52; P = 0.62). Interpretation: This study is the first randomized trial to show that RAL resulted in non-inferior overall survival compared with VAL in patients with resectable NSCLC. Based on our results, RAL is an equally oncologically effective treatment and can be considered as an alternative to VAL for resectable NSCLC. Funding: National Natural Science Foundation of China (82072557), National Key Research and Development Program of China (2021YFC2500900), Shanghai Municipal Education Commission-Gaofeng Clinical Medicine Grant (20172005, the 2nd round of disbursement), program of Shanghai Academic Research Leader from Science and Technology Commission of Shanghai Municipality (20XD1402300), Novel Interdisciplinary Research Project from Shanghai Municipal Health Commission (2022JC023), and Interdisciplinary Program of Shanghai Jiao Tong University (YG2023ZD04).

Early patient-reported outcomes after robotic-assisted versus video-assisted thoracoscopic lobectomy.

BACKGROUND: Robotic-assisted thoracoscopic surgery (RATS) can achieve traditional clinical outcomes comparable to those of video-assisted thoracoscopic surgery (VATS). However, patient-reported outcomes (PROs) during the early period after RATS and VATS remain unclear. This study aimed to utilize longitudinal electronic PRO (ePRO) assessments to evaluate symptom burden and functional status between these approaches from patients' perspective. METHODS: This study comprised patients who underwent lobectomy via RATS or VATS for non-small cell lung cancer. We collected multiple-time-point PROs data from the prospective longitudinal study via an ePRO system. Symptom severity and function status were assessed using the perioperative symptom assessment for patients undergoing lung surgery and were analyzed between groups using linear mixed-effects models. RESULTS: Of the 164 patients, 42 underwent RATS and 122 underwent VATS. After propensity score matching (PSM), 42 RATS and 84 VATS exhibited similar baseline characteristics. During the 7-day postoperative period, participants underwent RATS reported milder pain (p = 0.014), coughing (p < 0.001), drowsiness (p = 0.001), and distress (p = 0.045) compared with those underwent VATS. Moreover, participants in RATS group showed less functional interference with walking (p < 0.001) and general activity (p < 0.001). RATS exhibited a shorter postoperative hospitalization (p = 0.021) but higher hospital cost (p < 0.001). Meanwhile, short-term clinical outcomes of operative time, dissected lymph node stations, chest tube drainage, and postoperative complication rates were comparable. CONCLUSION: PROs are important metrics for assessing patients' recovery after lobectomy. Compared with VATS, RATS may induce less symptom burden and better functional status for patients in the early postoperative period.

Health-Related Quality of Life Following Robotic-Assisted or Video-Assisted Lobectomy in Patients With Non-Small Cell Lung Cancer: Results From the RVlob Randomized Clinical Trial.

BACKGROUND: Robot-assisted lobectomy (RAL) is increasingly used as an alternative to video-assisted lobectomy (VAL) for resectable non-small cell lung cancer (NSCLC). However, there is little evidence of any difference in postoperative health-related quality of life (HRQoL) between these two approaches. RESEARCH QUESTION: Is RAL superior to VAL in improving quality of life in patients with resectable NSCLC? STUDY DESIGN AND METHODS: We performed a single-center, open-label randomized clinical trial from May 2017 to May 2020 with 320 enrolled patients undergoing RAL or VAL for resectable NSCLC (RVlob trial; NCT03134534). Postoperative pain was evaluated by visual analog score or numeric rating score on postoperative day 1 and at weeks 4, 24, and 48. The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30), EORTC Quality of Life Questionnaire in Lung Cancer (QLQ-LC13), and the European Quality of Life 5 Dimensions (EQ-5D) questionnaire were also administered at weeks 4, 24, and 48 after surgery. RESULTS: One hundred and fifty-seven patients underwent RAL and 163 underwent VAL. The mean pain score of patients after RAL was significantly lower at week 4 (2.097 ± 0.111 vs 2.431 ± 0.108; P = .032). QLQ-C30 and QLQ-LC13 summary scores (P > .05) were similar for both RAL and VAL during the first 48 weeks of follow-up. HRQoL scores assessed with the EQ-5D questionnaire were also comparable between the two groups (P > .05) during the whole study period. INTERPRETATION: Both RAL and VAL showed satisfactory and comparable HRQoL and postoperative pain up to 48 weeks after surgery, despite some minor statistical differences at week 4. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT03134534; URL: www. CLINICALTRIALS: gov.

Robotic-assisted thoracoscopic surgery improves perioperative outcomes in overweight and obese patients with non-small-cell lung cancer undergoing lobectomy: A propensity score matching analysis.

BACKGROUND: The effectiveness of robotic-assisted lobectomy (RAL) for patients with non-small-cell lung cancer (NSCLC) has not been fully evaluated. METHODS: This retrospective study compared the perioperative outcomes of NSCLC patients who underwent RAL and video-assisted lobectomy (VAL) using propensity score matching (PSM) analysis. Subgroup analyses were then performed. RESULTS: A total of 822 NSCLC patients (359 RAL cases and 463 VAL cases) were included, and there were 292 patients in each group after PSM. Compared with the VAL group, the RAL group had a significantly higher number of lymph nodes (LNs) harvested (10 vs. 8, p < 0.001) and more LN stations examined (6 vs. 5, p < 0.001). The operative duration (95 minutes vs. 115 minutes, p < 0.001) and intraoperative estimated blood loss (65 mL vs. 80 mL, p < 0.001) were significantly reduced, and the drainage volume on postoperative day (POD) 1 (240 mL vs. 200 mL, p < 0.001) and hospitalization costs (¥81084.96 vs. ¥66142.55, p < 0.001) were significantly higher in the RAL group. Subgroup analysis indicated that the incidence of postoperative complications (17.9% vs. 26.7%, p = 0.042) was significantly reduced in the RAL group for overweight and obese patients (body mass index [BMI] ≥24 kg/m2 ), which became insignificant in the BMI < 24 kg/m2 subgroup (31.0% vs. 24.8%, p = 0.307). CONCLUSION: RAL might have potential advantages in terms of lymph node assessment, reducing intraoperative blood loss, and shortening operation duration. Overweight and obese patients could benefit more from RAL because of reduced risk of postoperative complications.

Preoperative thromboprophylactic administration of low-molecular-weight-heparin significantly decreased the risk of intraoperative bleeding compared with heparin in patients undergoing video-assisted lobectomy for lung cancer.

BACKGROUND: Due to the threat from venous thromboembolism (VTE) after major thoracic surgery, especially for cancers, guidelines recommend either heparin sodium (unfractionated heparin) or low-molecular-weight-heparin (LMWH) for those patients at high risk of deep vein thrombosis (DVT). However, risk of bleeding remains a major concern for pre-operative administration of anti-coagulation agents. Therefore, this study aimed to compare the bleeding risk of preoperative administration of LMWH and heparin in patients undergoing video-assisted thoracic surgery (VATS) lobectomy for lung cancer. METHODS: A retrospective, single-center study was designed. A total of 130 patients diagnosed with lung cancer were included from August 2016 to January 2018. These patients were divided into two groups. The preoperative administration of heparin group (PH group) had received heparin 5,000 IU, BID (twice a day) both pre- and post-operatively. And the LMWH group (PL group) had received LMWH 4,000 IU, QD (once a day) both pre- and post-operatively. These anticoagulants would not be ceased until patient was discharged or 24-hour postoperative chest drainage volume exceeded 500 mL. Both preoperative and postoperative coagulation parameters including platelet count (PLT), hemoglobin value (HGB), international normalized ratio (INR), prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (FIB), thrombin time (TT), postoperative drainage parameters and intraoperative bleeding volume were compared. RESULTS: A total of 62 patients were collected in PH group, while 68 patients comprised PL group. Preoperative coagulation parameters, hematologic data and demographic data were comparable. Preoperative duration of two agents (P=0.414), operation time (P=0.155), postoperative HGB (P=0.943), PLT (P=0.244), INR (P=0.469), PT (P=0.651), TT (P=0.407), FIB (P=0.151), drainage duration (P=0.800), duration of heparin and LMWH (P=0.778) were all comparable between the two groups. Compared with PL group, intraoperative bleeding volume (105.11 and 50.26, P<0.001) and postoperative mean drainage volume (251.52 and 216.90 mL, P=0.025) of PH group were significant more. Postoperative APTT (30.17 vs. 28.20 seconds, P=0.022) was significantly longer in PH group. CONCLUSIONS: Compared with preoperative administration of heparin, preoperative thromboprophylactic administration of LMWH significantly decreased the risk of intraoperative bleeding in VATS lobectomy.