Safety and Efficacy of the Novel SpydrBlade Flex With Radiofrequency and Microwave Ablation Flexible Bipolar for Colorectal Endoscopic Submucosal Dissection - A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- En-bloc resection rate
研究概览
简要总结
This study is an interventional, prospective, single-center study to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD in patients with superficial colorectal neoplasia.
详细描述
This is a prospective study with the following study Objectives:
- To evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD.
- To assess the impact of the procedure on patient recovery time and postoperative adverse event.
This study is an interventional, prospective, single-center study to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD in patients with superficial colorectal neoplasia. Patients will undergo a ESD for superficial colorectal neoplasia. All ESD procedures will be performed by expert endoscopists with at least 50 prior experience of ESD.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (age ≥18 and ≤80 years-old)
- •Capability of understanding and complying with the study requirements, including signing the informed consent form.
- •Patients with colorectal superficial mucosal neoplasia (clinically adenoma or early intramucosal cancer), scheduled to undergo endoscopic submucosal dissection (ESD).
排除标准
- •Patients unable or unwilling to provide consent.
- •Patients with lesions unsuitable for ESD, including those suspicious of deep submucosal invasive cancer.
- •Patients with lesions involving the appendiceal orifice or ileocaecal valve.
- •Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake monitored anesthesia for the procedure.
- •Poor performance status (Eastern Cooperation Oncology Group performance status ≥3).
- •Pregnant women or those planning pregnancy or breastfeeding women.
- •Uncorrectable coagulopathy defined by international normalized ratio (INR) > 1.5 or platelet count < 50000/µl.
研究组 & 干预措施
Endoscopic submucosal dissection with SpydrBlade Flex
This group of patient would undergo endoscopic submucosal dissection with the use of the novel SpydrBlade Flex knife
干预措施: Colorectal ESD with SpydrBlade Flex (Device)
结局指标
主要结局
En-bloc resection rate
时间窗: 30 days
Defined by complete macroscopic resection of the target neoplasia in one single specimen
次要结局
- R0 resection rate(30 days)
- Curative resection rate(30 days)
- Adverse event rate(30 days)
- Rate of adverse event - hemorrhage(30 days)
- Rate of adverse event - perforation(30 days)
- Rate of adverse event - post-ESD coagulation syndrome(30 days)
研究者
Hon Chi Yip
Assistant Professor
Chinese University of Hong Kong