Introduction: Radical cystectomy (RC) combined with pelvic lymph node dissection (PLND) is the principle for muscle invasive bladder cancer (MIBC), but it is unclear whether PLND is necessary for high-risk non-muscle invasive bladder cancer (NMIBC). Methods: From January 2021, patients diagnosed as high-risk NMIBC without swollen lymph nodes (or lymph nodes =8mm) on MRI/CT were prospectively enrolled, and randomly received RC+PLND or RC alone (NCT: 05123625). Perioperative clinical data, 90-day complications, and medical expenses, et al were recorded. The endpoint was progression-free survival (PFS) and overall survival (OS). All statistical analyses were performed in SPSS26.0 and R software (version 3.6.3). Results: As of September 19, 2022, a total of 63 patients were enrolled, with 40 patients received ileal conduit, 5 patients received orthotopic neobladder, and 18 received ureteral cutaneous diversion. Among all patients, 26 cases were in RC+PLND group, with the age of 65.5 (IQR: 57.25-72.75) years. Laparoscopic surgery was performed in 15 cases, robotic-assisted in 10 cases, and open surgery in 1 case due to excessive bleeding. Pathological stage was Ta/ Tis: 6 cases and T1: 20 cases. None positive lymph node was found. There were 37 cases in RC only group, with the age of 66 (IQR: 59-73) years. Laparoscopic surgery was performed in 7 cases, and robotic-assisted in 30 cases. Pathological stage was Ta/Tis: 6 cases and T1: 31 cases. The operation time of RC group was significantly shorter than that of RC+PLND group (241±63 min vs. 335±83 min, p < 0.001), and the intraoperative blood loss was significantly lower than that of RC+PLND group (p=0.026). The average daily postoperative drainage volume of patients in RC group was significantly less than that in RC+PLND group (p=0.002), and the time from postoperative to discharge was shorter (8.0±2.4 vs. 11.2±6.3 days, p=0.019). Within 90 days after operation, the incidence of Clavien-Dindo grade II-III complications in RC group were lower than that in RC+PLND group (2.7% vs 19.2%, p=0.073). At the median follow-up of 9.5 (IQR: 6.9-12.8) months, there was no significant difference in PFS and OS between the two groups (Figure 1). Conclusions: For high-risk NMIBC patients, combined PLND has no survival benefit but increases the incidence of complications. SOURCE OF Funding: None
