Robot-assisted Partial Nephrectomy with the Newly Developed KangDuo Surgical Robot Versus the da Vinci Si Surgical System: A Double-center Prospective Randomized Controlled Noninferiority Trial

摘要

BACKGROUND: The KangDuo surgical robot (KD-SR) was recently developed in China. OBJECTIVE: To compare the safety and efficacy of the KD-SR versus the da Vinci Si Surgical System (DV-SS-Si) for robot-assisted partial nephrectomy (RAPN). DESIGN, SETTING, AND PARTICIPANTS: A double-center prospective randomized controlled noninferiority trial of patients aged 18-75 yr with a suspicion of T1a N0M0 renal cancer (RENAL nephrometry score ≤9) was conducted. INTERVENTION: RAPN with the KD-SR versus the DV-SS-Si. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was the success rate of operation. The operation was successful if (1) there was no open or laparoscopic conversion, (2) the warm ischemia time was <30 min for RENAL nephrometry scores of 4-6 or 40 min for RENAL nephrometry scores of 7-9, and (3) the pathological margin was negative. The secondary endpoint was the estimated glomerular filtration rate (eGFR). A threshold of 10% was set to demonstrate noninferiority. RESULTS AND LIMITATIONS: From September 2020 to March 2021, 100 participants were enrolled, of whom 99 (49 in the KD-SR group and 50 in the DV-SS-Si group) were finally included in the full analysis set and 98 (49 in the KD-SR group and -49 in the DV-SS-Si group) in the per-protocol set. Baseline demographic and clinical characteristics were similar between the two groups. All surgeries were completed successfully. The eGFR at postoperative weeks 4-12 and adverse events were similar between the two groups. The docking time and suture time per stitch were longer in the KD-SR group. The main limitation was that a negative margin was considered as the primary outcome rather than survival. CONCLUSIONS: The KD-SR achieved noninferior outcomes as compared with the DV-SS-Si regarding safety and efficacy for T1a tumors. PATIENT SUMMARY: The first trial comparing the KangDuo surgical robot (KD-SR) versus the da Vinci Si Surgical System for robot-assisted partial nephrectomy showed that the KD-SR is a viable option for minimally invasive treatment of T1a renal tumors.