STELLA-2 Randomized Trial

Randomized trial on minimally-invasive (transperitoneal or extraperitoneal) paraaortic lymphadenectomy. The study objective was to evaluate if extraperitoneal paraaortic lymphadenectomy using a robotic-assisted approach was associated with fewer complications when compared to all other approaches (conventional laparoscopic transperitoneal or extraperitoneal and robotic-assisted transperitoneal) without compromising lymph node yield, operative time or length of stay. Design: Exploratory analysis of the prospective randomized open-label multicenter trial (STELLA-2) Setting: Three academic reference hospitals. Patients: Two-hundred and three eligible patients from STELLA-2 trial were included. Interventions: Patients were randomized to extraperitoneal or transperitoneal PALND using a minimally invasive approach (either laparoscopy or robotic-assisted) for surgical staging of endometrial or ovarian cancer. Measurements and Main Results: Primary endpoint was evaluated through a composite variable which included at least one of the following events: bleeding during PALND ≥ 500 mL, any intraoperative complication related to PALND, severe postoperative complication (Dindo ≥ IIIA), impossibility to complete the procedure or conversion to laparotomy). Of the 203 patients analyzed, 68 patients were assigned to the extraperitoneal laparoscopic group (X-L), 62 to the transperitoneal laparoscopic group (T-L), 35 to the extraperitoneal robotic group (X-R), and 38 to the transperitoneal robotic group (T-R). A reduced trend in complications was observed in the extraperitoneal robotic-assisted arm when considering the primary endpoint (X-L: 25.0%, T-L:24.2%, X-R: 5.7%; T-R: 28.9%, p=0.073). In a multivariable analysis, age (OR: 1.05, 95% CI: 1.00-1.09), body mass index (OR: 1.09, 95% CI: 1.03-1.16), and waist-hip ratio (OR: 1.66, 95% CI: 1.12-2.47) were found to independently increase the risk of PALND complications, while extraperitoneal robotic approach (OR: 0.13, 95% CI 0.02-0.64) was an independent protective factor for complication occurrence.微创（经腹腔或经腹膜外）腹主动脉旁淋巴结清扫术随机对照试验。本研究旨在评估相较于其余所有术式（常规腹腔镜经腹腔、常规腹腔镜经腹膜外以及机器人辅助经腹腔术式），采用机器人辅助经腹膜外路径的腹主动脉旁淋巴结清扫术（paraortic lymphadenectomy, PALND）是否可在不降低淋巴结清扫数目、不延长手术时长及住院时间的前提下，减少并发症发生风险。 研究设计：对前瞻性随机开放标签多中心试验（STELLA-2）进行探索性分析。 研究场景：3家学术标杆医院。 研究对象：纳入STELLA-2试验中203例符合入组标准的患者。 干预措施：将患者随机分配至采用微创路径（腹腔镜或机器人辅助）的经腹膜外或经腹腔PALND组，用于子宫内膜癌或卵巢癌的手术分期。 测量指标与主要研究结果：主要终点通过复合变量进行评估，该变量包含至少以下一项事件：PALND术中出血量≥500mL、任何与PALND相关的术中并发症、严重术后并发症（Dindo分级≥IIIA级）、无法完成手术或中转开腹。 在纳入分析的203例患者中，68例被分配至经腹膜外腹腔镜组（X-L）、62例至经腹腔腹腔镜组（T-L）、35例至经腹膜外机器人辅助组（X-R），另有38例至经腹腔机器人辅助组（T-R）。 针对主要终点分析可见，经腹膜外机器人辅助组的并发症发生风险呈降低趋势（X-L：25.0%，T-L：24.2%，X-R：5.7%；T-R：28.9%，p=0.073）。多变量分析结果显示，年龄（比值比OR=1.05，95%置信区间CI：1.00~1.09）、体质量指数（OR=1.09，95%CI：1.03~1.16）以及腰臀比（OR=1.66，95%CI：1.12~2.47）可独立升高PALND并发症发生风险，而经腹膜外机器人辅助术式（OR=0.13，95%CI：0.02~0.64）则是并发症发生的独立保护因素。