Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"- A Prospective Multicenter Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Technical success
研究概览
简要总结
Observational prospective multicenter study to investigate efficacy and safety of endoscopic full thickness resection in the lower GI tract using a novel over-the-scope full thickness resection device.
详细描述
The FTRD ("Full Thickness Resection Device", Ovesco Endoscopy, Tübingen, Germany) is an over the scope device consisting of a transparent cap with a preloaded monofilament snare and and a 14 mm modified Over-the-scope Clip. The device is CE marked for full thickness resection in the lower GI tract.
The study was designed to investigate efficacy and safety of this device for full thickness resection of colorectal lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age > 18 y
- •Adenoma with negtive lifting sign
- •Adenoma involving or next to a diverticulum
- •Adenoma involving or next to the appendical orifice
- •T1 carcinoma with indication for endoscopic (re-)resection
- •Subepithelial colorectal tumor with indication for resection
排除标准
- •Lesions >3 cm
- •T1 carcinomas with known high-risk features (submucosal infiltration>1000 um, invasion of lymphatic vessels, poor differentiation (G3))
- •Lesions in the upper GI tract
- •Patients with colorectal stenosis
- •Patinets not able to undergo informed consent
- •Pregnancy
- •Patients with urgent indication for dual thrombocyte aggregation inhibition
结局指标
主要结局
Technical success
时间窗: Immediate
Successful enbloc- and macroscopically complete resection
R0-Resection
时间窗: 3 days
Histologically confirmed complete resection
次要结局
- Necessity of surgical treatment(3 months)
- Residual or recurrent adenoma/carcinoma at endoscopic follow up(3 months)
- Histologically confirmed full thickness resection(3 days)
- Procedure-associated complications(3 months)
- Procedure time(immediate)