Department of Hepatobiliary and Pancreatic Surgical Oncology, Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Beijing, 100853, China.
Trials. 2020 Apr 3;21(1):306. doi: 10.1186/s13063-020-04250-0.
Data from meta-analysis suggest that robotic radical antegrade modular pancreatosplenectomy (RAMPS) is a safe and effective procedure for treating adenocarcinoma in the body or tail of the pancreas, and is oncologically superior to standard retrograde pancreatosplenectomy (SRPS). RAMPS is an operation that actively expands the scope of resection, and achieves a higher R0 resection rate and lymph nodes acquisition through expanded resection. However, previous studies on RAMPS were conducted under open and laparoscopic surgery. Robotic surgery, on the other hand, plays a role in ergonomics and offers several advantages, including less fatigue, tremor filtering, 7° of wrist-like motion, motion scaling, and three-dimensional vision. At present, there is still a world-wide lack of clinical studies to observe the safety and clinical efficacy of robotic RAMPS. Hence, prospective randomized controlled trials (RCTs) comparing robotic RAMPS and SRPS are required. We begin an RCT to compare short-term surgical and oncological outcomes of robotic RAMPS and SRPS in patients undergoing distal pancreatectomy.
This is a randomized, single-center clinical trial. All participants are adult patients with primary pancreatic cancer, who are undergoing RAMPS or SRPS. The primary endpoints are R0 rate (resection margins are classified by a margin to tumor distance ≥ 1 mm). The secondary endpoints are the number of harvested lymph nodes, perioperative complications and perioperative indicators (duration of surgery, blood loss, blood transfusion volume, costs).
We are undertaking a prospective RCT to evaluate the surgical and oncological outcomes of robotic RAMPS. This procedure may become a standard approach to robotic pancreatosplenectomy.
Chinese Clinical Trial Registry: ChiCTR1900020833, Registered on 20 January 2019.
荟萃分析的数据表明，机器人辅助顺行模块化胰脾切除术（RAMPS）治疗胰体尾腺癌是一种安全有效的方法，在肿瘤学方面优于标准逆行胰脾切除术（SRPS）。RAMPS 是一种积极扩大切除范围的手术，通过扩大切除实现更高的 R0 切除率和淋巴结获取。然而，之前关于 RAMPS 的研究是在开放和腹腔镜手术下进行的。机器人手术在人体工程学方面具有优势，具有减少疲劳、震颤过滤、7 度类似手腕的运动、运动缩放和三维视觉等优点。目前，仍然缺乏观察机器人 RAMPS 的安全性和临床疗效的全球临床研究。因此，需要进行比较机器人 RAMPS 和 SRPS 的前瞻性随机对照试验（RCT）。我们开始进行一项 RCT，比较机器人 RAMPS 和 SRPS 在接受胰体尾切除术的患者中的短期手术和肿瘤学结果。
这是一项随机、单中心临床试验。所有参与者均为原发性胰腺癌成年患者，接受 RAMPS 或 SRPS 治疗。主要终点是 R0 率（切除边缘通过肿瘤距离≥1mm 进行分类）。次要终点是淋巴结采集数量、围手术期并发症和围手术期指标（手术持续时间、出血量、输血量、费用）。
我们正在进行一项前瞻性 RCT，以评估机器人 RAMPS 的手术和肿瘤学结果。该手术可能成为机器人胰脾切除术的标准方法。
中国临床试验注册中心：ChiCTR1900020833，注册于 2019 年 1 月 20 日。
