NCT06943417尚未招募不适用
Safety and Efficacy of Endoscopic Full Thickness Biopsy With Over the Scope Clip in Patients With Chronic Intestinal Pseudo-obstruction: A Single-Center, Single-Arm, Open-label, Interventional Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of total perforations (intraoperative and delayed perforations)
研究概览
简要总结
To evaluate the safety and efficacy of endoscopic full thickness biopsy for the diagnostic purpose of chronic intestinal pseudo-obstruction.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic pseudo intestinal obstruction or suspected chronic pseudo intestinal obstruction
- •Patients who are 18 years of age or older at the time of obtaining consent
- •Gender: Any
排除标准
- •Patients for whom it is difficult to perform endoscopy
- •Patients who cannot obtain consent
- •Patients with serious renal, hepatic, or cardiac disease
- •Patients who are participating in other clinical research, except for observational research.
- •Other patients whom the principal investigator or subinvestigator determines to be inappropriate to conduct this study.
结局指标
主要结局
Percentage of total perforations (intraoperative and delayed perforations)
时间窗: Immediately after the intervention
Percentage of total perforations (intraoperative and delayed perforations)
次要结局
- Intraoperative perforation rate(Under procedure)
- Rate of delayed perforation(Periprocedural)
- Intraoperative complications(Under procedure)
- Intraoperative death rate(Under procedure)
- Examination time(Under procedure)
- Macroscopic specimen size(Immediately after procedure)
- Findings of tissue specimens(Immediately after procedure)
- Whether tissue evaluation is acceptable for biopsy purposes(Immediately after procedure)
- Ratio of postoperative complications(Immediately after procedure)
- Time or days of fluid intake postoperatively(From date of procedure until the date of first fluid intake assessed up to 12 months)
- Time or number of days of food intake after procedure(From date of procedure until the date of first food intake assessed up to 12 months)
- Length of hospital stay(From date of procedure until the date of discharge assessed up to 12 months)
研究者
研究点 (1)
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