Detachable String Magnetically Controlled Capsule Endoscopy for Complete Examination of Upper Gastrointestinal Tract and Small Bowel
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Success rate of UGI and small-bowel examination
研究概览
简要总结
This study aims to evaluate the feasibility and safety of DS-MCE with a novel way for complete examination in UGI tract and small bowel, compared with EGD.
详细描述
Magnetically controlled capsule endoscopy (MCE) has been widely used in clinical practice for upper gastrointestinal (UGI) tract and Small Bowel. However, the complete visualization of UGI tract still present challenges due to rapid transit through esophagus and duodenum, although technical improvements of MCE are helpful.
Detachable String MCE (DS-MCE) can control the movement of MCE through the string and MCE can start next examination after string detachment, which was proved to be an effective and safe method for complete viewing of the esophagus and stomach. In order to improve the duodenum visualization, endoscopist separate MCE from the string after finishing UGI examination so that can inspect the esophagus, stomach and duodenum under the string and magnetic field control.
This is a prospective, single-centered, self-controlled pilot study. Subjects with or without digestive symptoms receiving UGI endoscopy will be enrolled to take DS-MCE and conventional esophagogastroduodenoscopy (EGD) within 48h successively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients aged 18 to 80
- •With or without gastrointestinal complaints
- •Scheduled to undergo a capsule endoscopy for both stomach and small bowel
- •Signed the informed consents before joining this study
排除标准
- •Pacemakers or electromedical devices implanted which are incompatible with magnetic field;
- •Suspected or known gastrointestinal stenosis, obstruction or other known risk factors for capsule retention;
- •Scheduled magnetic resonance imaging examination before excretion of capsule;
- •Pregnancy or suspected pregnancy;
- •Any contraindications about EGD.
- •Other circumstances that doctors consider inappropriate for the study.
结局指标
主要结局
Success rate of UGI and small-bowel examination
时间窗: up to 2 weeks
The feasibility of DS-MCE examination with a novel way is evaluated by the technical success rate, a composite outcome including the successful separation of the string and MCE, repeat viewing of esophagus, stomach and duodenum, and complete small-bowel examination.
次要结局
- Image quality scores(up to 2 weeks)
- Detection rate of lesions(up to 2 weeks)
- Detection rate of Z-line, duodenal papilla and pyloric retrograde view(up to 2 weeks)
- Diagnostic accuracy(up to 2 weeks)
- Safety of DS-MCE procedure: presence of any adverse events during DS-MCE procedure will be recorded(up to 2 weeks)
- Circumferential visualization of the Z-line and duodenal papilla(up to 2 weeks)
- Cleansing level of Z-line and duodenal papilla area(up to 2 weeks)
- Visualization level of stomach(up to 2 weeks)
- Examination time of esophagus, stomach, duodenum and small bowel(up to 2 weeks)
- Pyloric transit time(up to 2 weeks)
- Discomfort scores associated with DS-MCE(up to 2 weeks)
研究者
Zhuan Liao
Clinical Professor
Changhai Hospital