Evaluation of the Efficacy and Safety of Magnetically-controlled Capsule Gastroscopy for Postoperative Assessment in Elderly Patients and Patients With Underlying Diseases

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Efficacy and Safety of Magnetically-controlled Capsule Gastroscopy for Postoperative Assessment in Elderly Patients and Patients With Underlying Diseases

Conditions
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Evaluation,Efficacy,Safety

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Magnetically-controlled Capsule endoscopy group<br>Using magnetic-controlled capsule gastroscopy for postoperative assessment in elderly patients and patients with underlying diseases | |
| Conventional endoscopy group<br>Using conventional endoscopy for postoperative assessment in elderly patients and patients with underlying diseases | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of gastric lesions (or postoperative complications) | Detection of gastric lesions (or postoperative complications) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper gastrointestinal discomfort symptoms or not | Patients have or no upper gastrointestinal discomfort symptoms after surgery (such as nausea, vomiting, acid reflux, belching, bloating, postprandial fullness, and early satiety), judging by the patient's chief complaint. | 1 day | 
| Patients' comfort during the procedure | Use BCS to evaluate patients' comfort during the procedure (BCS is Bruggrmann comfort scale, a 5-point scale of 0 to 4, with a higher score indicating higher comfort.) | 1 day | 
| Gastric clarity and visibility | Assess the clarity and visibility of the stomach. The clarity and visibility of the field of vision is divided into three categories, that is, class I: the field of vision is clear, and the part and mucosa can be accurately observed; Class II: Vision is not clear, but can still distinguish the part; Class III: Cloudy vision, unable to distinguish the area. | 1 day | 
| Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group | Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetically-controlled Capsule Endoscopy