The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Visualization rates of the ampulla of Vater
研究概览
简要总结
The aim of this study is to compare the visualization rates of the ampulla of Vater using forward- viewing endoscopes with or without cap attached to the distal end in the same patient.
详细描述
The complete visualization of the ampulla of Vater for the detection of ampullary neoplastic lesions is technically challenging with a forward-viewing endoscope. There are limited data in the relevant literature regarding the effectiveness of the Cap assisted forward viewing endoscope for accurate evaluation of the ampulla de Vater. Therefore, the aim of this study is to compare the visualization rates of the ampulla of Vater using forward-viewing endoscopes with or without cap attached to the distal end in the same patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cap-assisted endoscopy
- •Referral to endoscopic examination of ampulla of Vater
排除标准
- •Patients with surgically modified anatomy.
- •Obstruction of the upper gastrointestinal tract.
- •Contra-indication for endoscopy.
- •Absence of informed consent.
结局指标
主要结局
Visualization rates of the ampulla of Vater
时间窗: Up to 30 minutes during gastrointestinal endoscopy
次要结局
- Rates of complications for both groups.(Up to 3 hours after upper endoscopy)
- Need for additional sedation required for the Cap-assisted endoscopy.(Up to 30 minutes during upper endoscopy)
- Additional time required for Cap-assisted endoscopy(Up to 30 minutes during upper endoscopy)
研究者
Denise Peixoto Guimarães
Principal Investigator
Barretos Cancer Hospital