Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer: a Pilot Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- the number of muscular injuries
研究概览
简要总结
The goal of this clinical trial is to investigate whether the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system can improve the safety of the endoscopic submucosal dissection (ESD). It will also evaluate the efficacy of the system, such as whether it could reduce the procedure time and so on. The main questions it aims to answer are:
Does the use of the FASTER system reduce the number of muscular injuries, improving the safety of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Researchers will compare FASTER-assisted ESD and conventional ESD to evaluate the safety and efficacy of the FASTER system.
Participants will:
Be randomly assigned to the group with ESD using the traditional procedure or to the group with ESD assisted by the FASTER system.
Keep a diary of their symptoms after the procedure. ESD has gained widespread acceptance as the standard method for treating early-stage gastrointestinal cancers. Adequate exposure of the submucosa layer through effective tissue traction is vital for the safe and effective performance of ESD. The FASTER system is designed to overcome this technical difficulty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-
- •Patients with pathologically verified high-grade intraepithelial neoplasia (HGIN) or intramucosal carcinoma of the stomach.
排除标准
- •Patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis.
- •Patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery.
- •Patients have a history of gastric malignancy with previous radiotherapy or operative treatment leading to changes in gastric structure.
- •Patients have lesions with local recurrence after endoscopic resection.
- •Patients unable to obtain informed consent.
结局指标
主要结局
the number of muscular injuries
时间窗: Within 24 hours after the procedure.
Muscular injury is described as visible damage to the muscularis propria.
次要结局
- the incidence of muscular injury(Within 24 hours after the procedure.)
- the frequency of intraoperative hemorrhage(Within 24 hours after the procedure.)
- the proportion of intraoperative hemorrhage ≥ grade 2(Within 24 hours after the procedure.)
- hemostasis time(Within 24 hours after the procedure.)
- the frequency of supplemental injections(Within 24 hours after the procedure.)
- the supplemental injections time(Within 24 hours after the procedure.)
- procedure time(Within 24 hours after the procedure.)
- dissection time(Within 24 hours after the procedure.)
- direct-vision dissection rate(Within 24 hours after the procedure.)
- en bloc resection rate(Within 24 hours after the procedure.)
- R0 resection rate(Within 24 hours after the procedure.)
研究者
Xiuli Zuo
Professor, MD, PhD
Shandong University