Evaluation of the Efficacy and Safety of Magnetically-controlled Capsule Gastroscopy for Postoperative Assessment in Elderly Patients and Patients With Underlying Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Detection of gastric lesions (or postoperative complications)
研究概览
简要总结
The objective of this prospective, observational, controlled clinical study is to use magnetically-controlled capsule gastroscopy for postoperative assessment in elderly patients and patients with underlying diseases, to evaluate its clinical efficacy and safety.
详细描述
Gastric cancer is the most common digestive tract malignancy in China, which severely impacts human health and quality of life. Currently, surgery is the main treatment for gastric cancer. Since the surgery removes part or all of the stomach for malignant tumor, various postoperative complications inevitably occur. The occurrence of postoperative complications is detrimental to the prognosis of patients. Therefore, regular follow-up after surgery is necessary to closely monitor for upper gastrointestinal symptoms and periodically examine intragastric lesions in order to make timely diagnosis and treatment, and improve quality of life. Standard endoscopy procedures often cause discomfort and poor compliance in elderly patients. Also, for patients with severe respiratory diseases, severe cardiocerebral vascular diseases, the risks of anesthesia are extremely high. Magnetic-controlled capsule gastroscopy has the advantages of being completely painless, convenient, highly accurate in diagnosis, and well-accepted by patients. It is more suitable for postoperative assessment in elderly patients and patients with underlying diseases.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned to undergo magnetic-controlled capsule gastroscopy or conventional endoscopy, and have undergone surgery for gastric malignant tumors (including surgical resection and ESD), elderly patients (older than 65 years) or patients with underlying diseases (cardiovascular, respiratory, hemorrhagic diseases, etc.);
- •Agree to participate in this clinical trial and sign the informed consent form.
排除标准
- •No surgical conditions or refuses abdominal surgery (Once the capsule is stuck it cannot be removed surgically);
- •Cardiac pacemakers (except MRI-compatible ones);
- •Electronic implants or metal foreign bodies;
- •Pregnant women;
- •Known or suspected GI obstruction, stenosis, fistula;
- •Dysphagia.
结局指标
主要结局
Detection of gastric lesions (or postoperative complications)
时间窗: 1 day
Detection of gastric lesions (or postoperative complications)
次要结局
- Gastric clarity and visibility(1 day)
- Upper gastrointestinal discomfort symptoms or not(1 day)
- Patients' comfort during the procedure(1 day)
- Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group(1 day)
研究者
Xiaobo Li
Chief physician
Shanghai Jiao Tong University School of Medicine