Feasibility of the Third Space Robotic and Endoscopic Cooperative Surgery(TS-RECS) for Treating Gastric Stromal Tumor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- the rate of adverse events
研究概览
简要总结
The third space robotic and endoscopic cooperative surgery (TS-RECS) combines the endoscopic techniques and the merits of Da Vinci surgical robot, such as flexible and precise instruments, tremors filtering system and a 3-D surgical view. TS-RECS takes full advantage of the methodology of the third space, making it possible to dissect gastric GISTs (gastrointestinal stromal tumors) entirely without the damage of mucosal layer. Here, this study preliminarily assessed the feasibility, safety and effectivity of the novel hybrid operation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with gastric GISTs originating from muscularis propria diagnosed by EUS (endoscopic ultrasound)；
- •The maximal cross-sectional diameter of tumor ranging from 2cm to 5cm, or the maximal cross-sectional diameter of tumor <2cm but with malignant potential ( irregular shape, cystic space, heterogeneity and rapid growth during follow-ups ) ；
- •No evidence of tumor metastasis on all per-operative evaluations；
排除标准
- •Patients with serious systemic comorbidities, such as severe heart failure, respiratory failure, uncontrolled hypertension;
- •Patients with advanced malignant tumor;
- •Patients were required the emergency operation by complete intestinal obstruction, perforation and hemorrhage caused by the tumor;
- •4.Patients with ulcer penetration into tumors;
- •Patients with the contraindications for general anesthesia;
- •Patients were pregnant or younger than 18 years old；
研究组 & 干预措施
patients received treatment of TS-RECS
干预措施: the third space robotic and endoscopic cooperative surgery (Procedure)
结局指标
主要结局
the rate of adverse events
时间窗: through study completion, an average of 6 months
Adverse events included intraoperative adverse (full-thickness perforation, hemorrhage, injury of visceral organs and vessel, and anaesthesia complications), and postoperative adverse events (infectious complications, intra-abdominal /intraluminal bleeding, gastric stasis and leakage)
次要结局
- rate of en bloc resection(1 day)
- the rate of intact mucosal layer(1 day)
- operation time(1 day)
- estimated blood loss(1 day)
- time to oral diet(30 days)
- duration of postoperative hospital stay(30 days)