Analysis of Influencing Factors of Gastric Preparation Quality for Magnetically Controlled Capsule Gastroscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- GCS score was used to evaluate the quality of gastric preparation
研究概览
简要总结
The invention of magnetically controlled capsule gastroscopy makes the movement of capsule endoscope in the body controllable. Endoscopic doctors can adjust the angle of capsule observation to examine gastric mucosa according to the need of examination. However, The presence of food residue, air bubbles, mucus and bile in the gastric cavity will affect the observation of gastric mucosa by capsule endoscopy. it will reduce the completion rate of capsule endoscopy, and even lead to misdiagnosis and missed diagnosis. The purpose of this study is to explore the factors affecting the quality of gastroscopy gastric environmental preparation of magnetically capsule.
详细描述
Magnetically controlled capsule endoscopy is different from ordinary electronic gastroenteroscopy, it can not fill and clean the gastric cavity by water injection. The presence of food residue, air bubbles, mucus and bile in the gastric cavity will affect the observation of gastric mucosa by capsule endoscopy, reduce the completion rate of capsule endoscopy, and even lead to misdiagnosis and missed diagnosis, so the quality of MCCG gastric environmental preparation is an important factor limiting the accuracy of diagnosis of gastric lesions. We design the case report table by consulting the literature, and then collect patient information, and speculate the relevant influencing factors through the evaluation of the quality of gastric environmental preparation of the examination results. the ultimate goal is to reduce the missed diagnosis rate and misdiagnosis rate and the waste of clinical resources, to prepare the gastric environment more pertinently, and to provide certain guiding significance for the preparation of gastric environment in clinical magnetically controlled capsule endoscopy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients aged 18-75 years old who intend to undergo magnetron capsule gastroscopy, regardless of gender
- •sign informed consent form
排除标准
- •dysphagia, known or suspected gastrointestinal obstruction、stricture and fistula
- •patients with severe somatic diseases unable to complete examination
- •known active upper gastrointestinal bleeding
- •previous history of upper digestive tract or abdominal surgery to change
- •gastrointestinal anatomy
- •patients with cardiac pacemakers or implanted with other electronic medical
- •instruments and magnetic metal foreign bodies
- •pregnant women
- •claustrophobia or other mental disorders uncontrollable
结局指标
主要结局
GCS score was used to evaluate the quality of gastric preparation
时间窗: 24 months
GCS score was used to evaluate the quality of gastric preparation. GCS was defined as the sum of the scores of six major anatomical markers of the stomach (heart, fundus, body, horn, sinus, and pylorus).A 4-point grading system was used to define cleanliness as excellent (no mucus and foam attachment :4 points);Good (there is a small amount of mucus and foam, but it does not affect the test: score 3 points);Average (with a fair amount of mucus or foam).Failure to complete a completely reliable examination :2 points);Poor (large amount of mucus or foam residue :1 point).The GCS is the total score for all six landmarks, ranging from 6 (completely unprepared) to 24 (perfect).Gastric preparation was defined as sufficient when GCS≥18 and insufficient when GCS\<18.
Questionnaire data were used to analyze the influencing factors
时间窗: 24 months
Before the examination, the subjects were required to fill in a questionnaire about the influencing factors of the quality of stomach preparation. According to GCS, the subjects were divided into fully prepared group and inadequately prepared group. Finally, statistical analysis was used to find the influencing factors that had statistical significance with the quality of stomach preparation according to the questionnaire content.
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(24 months)
- The number of positive lesions(24 months)
研究者
Yanqing Li
Vice president of QiLu Hospital
Shandong University