Magnetic-assisted Capsule Endoscope System With or Without 3D Images in Esophageal Varices Detection Compared With Conventional Esophagogastroduodenoscopy in Cirrhotic Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- esophageal detection rate
研究概览
简要总结
Newly development of capsule endoscopy provides a comfortable and minimal invasive modality which is an alternative to conventional esophagogastroduodenoscopy(EGD). The use of capsule endoscopy beyond the small bowel is increasing and several capsule endoscopy systems have been introduced for the examination of the esophagus and colon. The current capsule endoscopy systems are less effective for the upper gastrointestinal tract examination. Short transit time in the esophagus and the passive movement of the capsule makes it more difficult to identify or visualize the lesion comparing with traditional EGD. The sensitivity rate of esophageal varices detection from capsule endoscopy was ranging from 65% to 80%. In order to control the capsule in the gastrointestinal tract for better visualization, many methods are invented. Magnetically assisted capsule endoscopy systems and string-mounted capsule endoscopy are applied in many studies. Magnetically assisted capsule endoscopy system and string-mounted capsule endoscopy are used to control the capsule endoscopy for elongating esophagus transit time to have a better visualization of the esophagus. The InsightEyes EGD System combines the string and magnetic assisted capsule endoscopy system to provide a real-time high-quality image during the examination. On the other hand, 3D image processing can be used for distinguishing the esophageal varices and normal folds well, theoretically. Thus, in this study, the investigators combine string, magnetically assisted capsule endoscopy systems, and 3D image processing together to form a new system for improving the detection of esophageal varices and other gastric lesions.
详细描述
This is a prospective and observational study. Sample size calculation and patient selection The investigators plan to include a total of 140 participants in this study. Sixty-five cirrhotics with portal hypertensive symptoms (such as platelets count less than 100,000) will be enrolled to evaluate for the presence and stage of esophageal varices by using a magnetic-assisted capsule endoscope system. Thirty-five cirrhotics patients with history of endoscopy-confirmed esophageal varices will be included for the follow-up examination by using the magnetic-assisted capsule endoscope system. Another 40 healthy volunteers without known gastrointestinal disease will be enrolled as the control group. Those participants with less than 20-year-old, having implanted electronic or magnetic devices, pregnant, or unable to swallow the capsule, will be excluded from the study.
Intervention The patient will undergo both diagnostic tests in two days, with a magnetic-assisted capsule endoscope system first and then conventional EGD will be carried on at least 4 hours afterward.
Magnetic-assisted capsule endoscope system (MACE, InsightEyes EGD System) with or without 3D images("MedicalTek" Endoscopic Imaging system and accessories) will be used for detecting esophageal varices and other possible lesions. As standard per-endoscopy preparation, patients undergo a 6-8 hour fast. The participants take 400 mg of N-acetylcysteine solution in 200 mL of water 1 h before the MACE examination and an additional 300 mL of clear water after 30 min to remove gastric mucus. With the upright(sitting) position, the patient is instructed to swallow the capsule with 20mL of clear water. The hand-held magnet is held above the sternum in order to catch the capsule and examine the esophagus. Capsule endoscopy is manipulated by changes in the patient's position and hand-held magnet. The magnetic field navigator is placed in front of the patient's abdomen and helped the capsule moving and rotating by moving the magnetic field navigator.
The capsule endoscopy will end up in the second portion of the duodenum as the conventional EGD does.
The lesion is detected using 2D and 3D imaging at the same time during the examination.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The investigators plan to include a total of 140 participants in this study, aged from 20 to 75-year-old.
排除标准
- •Those participants with less than 20-year-old, having implanted electronic or magnetic devices, pregnant, or unable to swallow the capsule, will be excluded from the study.
结局指标
主要结局
esophageal detection rate
时间窗: upto 1 week after MACE and EGD
The investigators compare the detection rate of esophageal varices in the cirrhotic patients in the MACE system and 3D image processing with conventional EGD.
esophageal grading
时间窗: upto 1 week after MACE and EGD
The investigators compare the grading consistency in the patients who have the esophageal varices between the two modalities, using the conventional EGD as gold standard.
次要结局
- gastric lesion comparison(upto 1 week after MACE and EGD)
- image quality(upto 1 week after MACE and EGD)
- preference in MACE or EGD(upto 1 week after MACE and EGD)