Endoscopic Resection of Non-ampullary Duodenal Adenomas: Endoscopic Mucosal Resection (EMR) vs. Endoscopic Full-thickness Resection With the 'Duodenal Full-thickness Resection Device' (dFTRD)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Complication Rate
研究概览
简要总结
Prospective, randomized multi-center trial. Comparison of Endoscopic Mucosal Resection (EMR) versus Endoscopic Full-Thickness Resection with the duodenal Full-Thickness Resection Device (dFTRD) of non-ampullary duodenal adenomas.
详细描述
Prospective, randomized multi-center trial. Comparison of Endoscopic Mucosal Resection (EMR) versus Endoscopic Full-Thickness Resection with the duodenal Full-Thickness Resection Device (dFTRD) of non-ampullary duodenal adenomas.
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
- 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
- •duodenal adenoma
- •age 18 or older
- •written informed consent
排除标准
- •duodenal adenomas with a size > 25 mm
- •duodenal adenomas with 20 mm or less distance to the major and/or minor duodenal papilla
- •presence of two or more duodenal adenomas
- •suspected or histologically confirmed malignancy
- •tumor disease (exception: after successful curative treatment)
- •conditions/diseases of the upper GI-tract that impair advancing of the devices into the duodenum
- •moribund patient
- •pregnancy and breastfeeding
- •patients that cannot give informed consent (e.g. psychiatric disorders, language barrier,...)
- •other contraindications for duodenal resections
研究组 & 干预措施
dFTRD
Endoscopic full-thickness resection of the duodenal adenoma with the 'duodenal Full-Thickness resection device' (dFTRD).
干预措施: dFTRD (Procedure)
EMR
Endoscopic Mucosal Resection (EMR) of the duodenal adenoma (=standard therapy).
干预措施: EMR (Procedure)
结局指标
主要结局
Complication Rate
时间窗: 30 days
Composite endpoint of perforations and relevant bleeding
次要结局
- Need of secondary surgical intervention(3 months)
- 'R0'-Resection(within one week after resection (as soon as result of pathologic analysis of resected specimen is available))
- Rate of 'en bloc' resections(within one week after resection (as soon as result of pathologic analysis of resected specimen is available))
- Technical success(intraoperative)
- Procedure time(30 days)
- Duration of hospitalization(30 days)
- number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 3 months(3 months)
- number of necessary re-endoscopies(3 months)
- number of patients with residual or recurrent duodenal adenoma at the follow-up endoscopy after 1 year(1 year)