Motorized Spiral Enteroscopy-assisted ERCP in Surgically Altered Anatomy
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Success rate of MSE-ERCP
研究概览
简要总结
Patients with surgically altered anatomy receiving Motorized Spiral Eneroscopy (MSE)-assisted ERCP at a single endoscopic reference center for various indications are planned to be retrospectively enrolled
详细描述
All consecutive patients with altered upper gastrointestinal anatomy after Billroth-II- or Roux-en-Y reconstructive surgery and indication for ERCP with biliary and/or pancreatic indication, who underwent routine Enteroscopy-assisted ERCP using MSE, at the study center during the study period, will be enrolled in the analysis.
Primary endpoint of the study will be efficacy and safety of MSE-assisted ERCP.
Retrospective epidemiologic Study (not interventional) was approved by local IRB and ethical committee of the North-Rhine Chamber of Physicians (Düsseldorf, Germany), Reference Number: 177/2021.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •altered upper gastrointestinal anatomy after Billroth-II- or Roux-en-Y reconstructive surgery
- •indication for ERCP with biliary and/or pancreatic indication
- •Enteroscopy-assisted ERCP using MSE, at the study center during the study period
排除标准
- •due to the retrospective design of the study, no exclusion criteria are defined
结局指标
主要结局
Success rate of MSE-ERCP
时间窗: intraprocedural
rate of subjects with successfull MSE-assisted ERCP
Adverse event rate of MSE-ERCP
时间窗: 3 days
rate of adverse events during and early after MSE-ERCP
次要结局
- Procedural duration(intraprocedural)
- Success rate of enteroscopy(intraprocedural)