A New Method To Reduce Gastric Missing Areas in Capsule Endoscopy: a Single Center, Prospective and Self-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- visualization of gastric mucosa
研究概览
简要总结
It is a single center, prospective and self-controlled trial. We'd like to explore a new method by changing position to reduce gastric missing areas in Capsule Endoscopy(CE)
详细描述
Background:Capsule endoscopy is widely used to observe small intestine.While it may miss important areas in stomach，especially in fundus.So far,physicians have no methods to observe stomach without no-missing areas by capsule endoscopy.
Objective
To explore a new method to reduce the areas missed by CE.
Methods:Subjects were prospectively enrolled.Every subjects will undergo 2 capsule endoscopies and 1 gastroscope.First capsule endoscopy,every subject have a better gastric preparation before swallowing CE and change position during the procedure.Second capsule endoscopy,every subject have a conventional CE. And then, every subject have a gastroscope.
Measurements:The primary measurements included safety, gastric preparation, visualization of gastric mucosa and rate of lesion detection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects don't have swallowing difficulties, motility disorders, or a medical history that included abdominal surgery or obvious gastrointestinal strictures are included.
排除标准
- •Subjects with swallowing difficulty, motility disorders, diabetes, life-threatening conditions, mental disorders, or patients that could be pregnant, have a cardiac pacemaker, electrical implant, or any other condition that would preclude compliance with the study requirements and/or device instructions are excluded from the study.
结局指标
主要结局
visualization of gastric mucosa
时间窗: 1 year
Gastric preparation included the degree of cleanliness and distention.Cleanliness was evaluated by 3 grades: good (the fluid was transparent and \<5% of gastric mucosa was obscured by stomach contents), moderate (the fluid was a little opaque or 5% to 10% of gastric mucosa was obscured by stomach contents) and poor (the fluid was opaque or \>10% of gastric mucosa was obscured by stomach contents). Distention was evaluated by 3 grades: good (existence of a small amount of gastric folds), moderate (existence of significant amount of gastric folds and gastric cavity was smaller than expected) and poor (gastric cavity was not inflated).
次要结局
- rate of lesion detection(1 year)
研究者
Side Liu
professor,MD,phD
Nanfang Hospital, Southern Medical University