Safety and Efficacy of a Novel Intelligent Navigation 4K UHD 3D Endoscopic Imaging System in Laparoscopic Gastrectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 67
- 主要终点
- The success rate of laparoscopic gastric surgery
研究概览
简要总结
This study aims to evaluate the safety, efficacy, and feasibility of the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System in patients with gastric cancer.
详细描述
Background: Lymphadenectomy in laparoscopic gastrectomy can significantly improve the long-term survival and accuracy of the tumor staging of patients with gastric cancer. The retrieval of more lymph nodes has gradually become a trend among surgeons. However, lymphadenectomy is currently performed without the aid of visual instruments which might lead to an unknown pathological outcome and influence the prognosis of gastric cancer patients. And none of the indocyanine green (ICG) fluorescent imaging systems applied in clinical practice now is equipped with ultra-high definition (4K) or three-dimensional (3D) lens. To explore the advent of minimally invasive surgery with a conveniently switchable high-quality imaging system, we designed a new laparoscopic navigating technique that combined all the three characteristics.
Aims: This study aims to evaluate the safety, efficacy, and feasibility of the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System in patients with gastric cancer.
Methods/design This is a prospective, one-arm, single-center, single-set target value clinical trial to investigate the clinical value of the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System on laparoscopic gastric surgery. The trial will recruit a total of 67 participants.
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
- •Diagnosed with gastric cancer require surgery;
- •Without a history of abdominal surgery;
- •BMI ≤ 30 kg/m2;
- •Preoperative ECOG score is 0~1 and ASA score is I~III;
- •Having signed the Medical Informed Consent.
排除标准
- •Patients with metastasis or invasion of surrounding tissues;
- •Undergoing emergency operation (perforation, hemorrhage, obstruction);
- •Patients with serious medical co-morbidity (heart, lung, liver and kidney diseases) and could not tolerate laparoscopic surgery;
- •With poor incorrigible physical condition before surgery;
- •The patient who underwent gastrojejunostomy or jejunostomy;
- •The patient who refuses to accept standardized postoperative systemic therapy according to the guidelines.
结局指标
主要结局
The success rate of laparoscopic gastric surgery
时间窗: 24 months
Rate of successfully performed laparoscopic gastrectomy
次要结局
- Lymph node dissection rate(24 months)