Robotic Gastrectomy With a Novel 5th Arm - an International Multicenter Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Technical success
研究概览
简要总结
This is a multicenter single arm clinical pilot study to investigate the safety and feasibility of a novel multiport Sentire Robotic Surgical System with Patient Side Single Arm (5th arm) in patients with gastric cancer undergoing robotic radical gastrectomy. 10 adult patients with newly diagnosed cancer of the stomach deemed operable would be recruited from Prince of Wales Hospital, Hong Kong and Fujita Health University Hospital, Nagoya, Japan.
The primary aim of this study is to determine the feasibility of robotic surgical procedures performed using the Cornerstone Robotics Sentire Surgical System C1000 Ultra, as measured by the technical success rate of surgery, and to evaluate the safety of the procedures as measured by the incidence of perioperative complications.
详细描述
Laparoscopic surgery is a well-established minimally invasive surgery (MIS) technique, and is currently the standard treatment approaches for various benign and malignant surgical diseases of the abdomen [1]. In comparison with traditional open surgery, where a large surgical incision is made, laparoscopic surgery uses three to six small (0.5-1.5 cm) incisions to complete similar operative procedures. Based on numerous randomized controlled trials, minimally invasive surgeries have been proven to be beneficial in reducing patient trauma and morbidity, expediting postoperative recovery, and improving cosmesis when compared with open surgery [2,3].
The quest to develop precise and safe MIS in order to further reduce surgical trauma and improve patients' outcome still remains robust. Robotic technologies are expected to overcome the technical challenges associated with conventional laparoscopic surgery, including the limitation in degree of freedom associated with conventional laparoscopic instruments as well as lack of precision for dissection. The da Vinci Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA, USA) was initially developed in 1999 to address the technical disadvantages of conventional laparoscopic surgery in terms of visualization and maneuverability. The robotic system provides a stable camera platform with magnified 3D view, and intuitively transfers movements from the handle to the tip of the instrument with tremor filtering. Dexterity is enhanced via EndoWrist technology, returning seven degrees of freedom to the surgeon [4].
Despite its technical advantages, robotic surgery has always been criticized for being highly expensive, which has limited its accessibility and wider applications [5,6]. The current da Vinci Surgical System from Intuitive Surgical has high performance with excellent quality. However, the high cost for each robotic surgical procedure has imposed major financial impact to patients and hospitals. In order to provide a cost-effective solution, introduction of new robotic systems with similar quality of performance and lower instalment /maintenance costs is necessary.
Robotic Surgery in Gastric Cancer Surgery Laparoscopic surgery, is widely accepted as curative treatment for gastric cancer (GC). Several multicentre randomized clinical trials (RCTs) have reported lower rates of postoperative complications in patients who underwent laparoscopic gastrectomy (LG) compared with open gastrectomy, but with similar long-term prognosis between them [7-11]. Laparoscopic gastrectomy still has several drawbacks, however, including the limited range of movement, amplification of operator hand tremors, and inconvenient surgical positioning [12-16]. Specifically, for D2 lymphadenectomy, laparoscopic instruments lack the dexterity during supra-pancreatic dissection leading to pancreatic injury [12-13].
With the technical advantages described above, robotic gastrectomy (RG) may therefore overcome some of the drawbacks associated with LG. An RCT from China has shown that RG is associated with better short term outcomes such as lower morbidity rate, faster recovery, milder inflammatory responses, and improved lymphadenectomy [17]. The 3-year oncological outcome of the same trial also showed that RG has improved 3-year DFS and cumulative recurrence rate [18]. Another RCT from Japan reported a significantly lower postoperative surgical complications of Clavien-Dindo Grade II or higher although did not show difference in intra-abdominal infectious complications [19].
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75
- •Body mass index <35 kg/m2
- •Newly diagnosed tumors of the stomach / gastro-esophageal junction, scheduled to undergo elective gastrectomy (Proximal gastrectomy, distal gastrectomy, total gastrectomy)
- •Willingness to participate as demonstrated by giving informed consent
排除标准
- •Previous abdominal surgery precluding performance of MIS gastrectomy
- •Contraindication to general anesthesia
- •Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
- •Untreated active infection
- •Noncorrectable coagulopathy
- •Presence of another malignancy or distant metastasis
- •Emergency surgery
- •Vulnerable population (e.g., mentally disabled, pregnancy)
研究组 & 干预措施
5th arm group
干预措施: Robotic gastrectomy performed with Cornerstone Robotics Sentire Surgical System C1000 Ultra (With Patient Side Single Arm) (Device)
结局指标
主要结局
Technical success
时间窗: 1 day
Successful completion of the intended surgical procedure using the Sentire Surgical System C1000 Ultra, without conversion the treatment plan to conventional minimally invasive laparoscopic surgery or to open surgery.
次要结局
- Intra-operative complication(1 day)
- Post-procedural complication(30 days or in-hospital)
- Post-procedure hospital stay(3 months)
- Lymph node harvest(30 days)
- Cancer Recurrence(2 years)
- Operative time(1 day)
- Post-operative pain score(7 days)
- Intraoperative blood loss(1 day)
- Resection margin status(30 days)
研究者
Hon Chi Yip
Assistant Professor
Chinese University of Hong Kong
