国产多孔机器人手术系统在胰体尾切除术中应用的前瞻性、单中心、单臂探索性研究

Clinical application of domestic multi-port robot-assisted surgery system in distal pancreatectomy:a prospective,single-center,single-arm exploratory study

目的探索国产图迈多孔机器人手术系统在胰腺肿瘤患者胰体尾切除术中应用的安全性和有效性。方法本研究为一项前瞻性、单中心、单臂研究。前瞻性连续纳入2023年3月至11月于上海交通大学医学院附属瑞金医院治疗的20例胰腺肿瘤患者,其中男性13例,女性7例,年龄(57.9±11.2)岁。所有患者均使用图迈多孔手术机器人,行机器人辅助胰体尾切除术,分析并发症情况(依据Clavien-Dindo系统分级)、术中出血量、手术时间、术后引流管留置时间、术后病理等。结果20例患者均顺利完成手术,仅有1例(5.0%)诊断为胰腺神经内分泌肿瘤(G1期),其余为胰腺良性肿瘤,包括浆液性囊腺瘤、黏液性囊腺瘤等。未发生与器械相关的器官或血管损伤,无术中并发症发生,有7例(35.0%)患者发生了术后并发症,其中3例为感染、3例为腹腔积液、1例低钾血症。根据Clavien-Dindo分级系统,除1例腹腔积液为Ⅱ级外,其余均为Ⅰ级,未发生Ⅲ级及以上严重并发症。20例患者术中出血量为100(20,200)ml,手术时间为(125.7±76.9)min,术后引流管留置时间为(7.9±3.4)d。结论国产图迈多孔手术机器人系统在胰体尾切除临床应用中具有可接受的安全性和有效性。

Objective To explore the safety and efficacy of Tumai domestic multi-port robot-assisted surgery system in the clinical application of distal pancreatectomy in pancreatic tumor patients.Methods A prospective,single-center,single-arm exploratory study was conducted.A total of 20 patients who underwent robot-assisted pancreatic body-tail resection in Ruijin Hospital,Shanghai Jiao Tong University School of Medicine from March 2023 to November 2023 were enrolled,including 13 males and 7 females,aged(57.9±11.2)years.All the patients underwent robot-assisted distal pancreatectomy with Tumai multi-port surgical robot.Clinical data of complications,intraoperative blood loss,operative time,postoperative drainage tube retention time,and postoperative pathology were collected and statistically analyzed.Results All the 20 patients underwent surgery successfully.Only 1 patient(5.0%)was diagnosed with pancreatic neuroendocrine tumor(G1 stage),and the rest were benign pancreatic tumors,including serous cystadenoma and mucinous cystadenoma.No instrument-related organ or blood vessel injury occurred,no intraoperative complications occurred.Of 7 patients(35.0%)had postoperative complications,including 3 infections,3 abdominal effusion,and 1 hypokalemia.According to the Clavien-Dindo grading,all the cases were gradeⅠexcept 1 case with gradeⅡabdominal effusion.No serious complications above gradeⅢoccurred.The intraoperative blood loss of the 20 patients was 100(20,200)ml,the operative time was(125.7±76.9)min,and the postoperative retention time of drainage tube was(7.9±3.4)d.Conclusion Tumai domestic multi-port robot-assisted surgery system has acceptable safety and efficacy in the clinical application of distal pancreatectomy.