Pd11-04 comparing endoscopic robot-assisted simple enucleation and standard robot-assisted partial nephrectomy for t1 renal cell carcinoma: initial results of a non-inferiority randomized controlled trial

You have accessJournal of UrologyKidney Cancer: Localized: Surgical Therapy II (PD11)1 Apr 2020PD11-04 COMPARING ENDOSCOPIC ROBOT-ASSISTED SIMPLE ENUCLEATION AND STANDARD ROBOT-ASSISTED PARTIAL NEPHRECTOMY FOR T1 RENAL CELL CARCINOMA: INITIAL RESULTS OF A NON-INFERIORITY RANDOMIZED CONTROLLED TRIAL Qun Lu*, Xiaozhi Zhao, Changwei Ji, Guangxiang Liu, Linfeng Xu, and Hongqian Guo Qun Lu*Qun Lu* More articles by this author , Xiaozhi ZhaoXiaozhi Zhao More articles by this author , Changwei JiChangwei Ji More articles by this author , Guangxiang LiuGuangxiang Liu More articles by this author , Linfeng XuLinfeng Xu More articles by this author , and Hongqian GuoHongqian Guo More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000845.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Nephron-sparing surgery is the gold standard treatment for localized renal masses. Although published studies have showed excellent long-term oncologic results of simple enucleation (SE), many urologists still consider SE an unsafe technique with a high risk of incomplete tumor excision. This is a non-inferiority, randomized controlled trial to compare the peri-operative, renal functional and oncologic outcomes of endoscopic robot-assisted simple enucleation (ERASE) and standard robot-assisted partial nephrectomy (RAPN) in the treatment of T1 renal cell carcinoma (RCC). METHODS: Patients with newly diagnosed sporadic, unilateral, T1 presumed RCC were recruited for this clinical trial from October 2018. This trial was registered in ClinicalTrials.gov (NCT03624673). The protocol had been approved by the ethics committee of Nanjing Drum Tower Hospital. The inclusion criteria were clinical T1 RCC, age 18 to 80 years, normal contralateral renal function, RENAL score <=9 and willingness to participate in this study. The exclusion criteria were intolerance of robotic surgery, metastastic renal cell carcinoma, entry into collection system or hematuria and a history of other renal diseases. The primary outcome measure was rate of positive surgical margin (PSM). The Surface–Intermediate–Base margin score was reported for each tumor specimen. On the basis of the assumption of no difference in PSM rate between two techniques, we calculated that 190 participants per group were needed. RESULTS: The trial had presently enrolled 180 patients, of whom 90 were randomized to the ERASE group and 90 to the RAPN group. Demographic characteristics were similar. Mean operative time was 162.0 and 169.9 min, respectively (p=0.297). Warm ischemic time was comparable in the ERASE and RAPN group (18.7 vs 21.3 min; p=0.056). The estimated blood loss was similar (p=0.129). Tumor bed suturing was performed in 8.9% and 83.3% of ERASE and RAPN cases (P=0.000). No hilar clamping was performed in 8 (8.9%) ERASE patients and 5 (5.6%) RAPN patients (p=0.388). The rates of intraoperative and postoperative complications were similar. The incidence of PSMs was comparable between the ERASE and RAPN groups (2.2% and 3.3%, p= 1.000). No recurrence was found in the two groups during follow-up. CONCLUSIONS: The initial results of this trial reveal that ERASE is an oncologically safe and effective alternative to RAPN for T1 renal cell carcinoma. ERASE confers comparable peri-operative and oncologic results with RAPN, with similar incidence of PSM. The final results of this trial are required to validate our findings. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e254-e254 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Qun Lu* More articles by this author Xiaozhi Zhao More articles by this author Changwei Ji More articles by this author Guangxiang Liu More articles by this author Linfeng Xu More articles by this author Hongqian Guo More articles by this author Expand All Advertisement PDF downloadLoading ...