Second-generation Versus First-generation Magnetically Controlled Capsule Gastroscopy for Upper Gastrointestinal Tract: a Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Circumferential Visualization of the Z-line
研究概览
简要总结
The aim of this study is to evaluate the clinical application of the second-generation MCCG with higher image resolution and frame rate for upper gastrointestinal tract compared with the first-generation.
详细描述
Magnetically controlled capsule gastroscopy (MCCG) has been widely used in clinical practice for gastric examination. However, there still exist blind spots under MCCG, particularly in the esophagus and duodenum. Although the anatomy of the esophagus and duodenum can be the main cause, MCCG still needs technical improvement. In addition, the gastric examination time under MCCG can be further optimized.
Therefore, a new-generation MCCG is developed with a higher frame rate improved from 0.5-2 to 0.5-8 frames per second, image resolution improved from 480 x 480 to 720 x 720, view angle improved from 140° to 150°, wireless anti-jamming technology is applied as a more effective and stable information transmission method.
This is a prospective, single-centered, blinded randomized controlled pilot study. Subjects receiving MCCG at Changhai Hospital will be randomly allocated into two groups with a ratio of 1:1 before the procedure, the first-generation or the second-generation MCCG. After passage through the esophagus, the gastric examination and transpyloric passage of the capsule is conducted under magnetic steering, and then examination is continued in the small bowel under intestinal peristalsis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •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
- •Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy
- •Refused abdominal surgery to take out the capsule in case of capsule retention
- •Implanted pacemaker, except the pacemaker is compatible with MRI
- •Other implanted electromedical devices or magnetic metal foreign bodies
- •Pregnancy or suspected pregnancy
研究组 & 干预措施
The second-generation MCCG group
All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
干预措施: the second-generation MCCG (Device)
The first-generation MCCG group
The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
结局指标
主要结局
Circumferential Visualization of the Z-line
时间窗: Through end of examination, up to 30 minutes
Circumferential visualization of the Z-line is defined by quadrants as follows: less than 2 quadrants (\< 50%) of the Z line observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (\>75%) observed; and entire Z line (100%) observed.
次要结局
- Detection Rate of Duodenal Papilla(up to 2 days after the examination)
- Image Quality Score (Mainly Focus on Clarity)(up to 30 minutes after the examination)
- The Incidence of Adverse Events (The Safety of MCCG)(up to 2 weeks after the examination)
- Gastric Examination Time (GET)(Through end of examination, up to 30 minutes)
- Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time(up to 2 days after the examination)
- Cleansing Level Score of Z-line Area(Through end of examination, up to 30 minutes)
- Manipulation Performance Score of the MCCG(up to 10 minutes after the examination)
- The Number of Images Captured for Esophagus and Z-line(up to 30 minutes after the examination)
- Number of Participants With Lesions in Upper Gastrointestinal Tract(up to 2 days after the examination)
- Transit Time of MCCG in Esophagus(up to 2 days after the examination)
研究者
Zhuan Liao
Clinical Professor
Changhai Hospital