Evaluation,Efficacy,Safety
Conditions
Keywords
Magnetically-controlled Capsule Endoscopy
Brief summary
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
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.
Interventions
None listed
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of gastric lesions (or postoperative complications) | 1 day | Detection of gastric lesions (or postoperative complications) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper gastrointestinal discomfort symptoms or not | 1 day | 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. |
| Patients' comfort during the procedure | 1 day | 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.) |
| Gastric clarity and visibility | 1 day | 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. |
| Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group | 1 day | Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group |
Countries
China
Contacts
Primary ContactHui-Min H Chen, MD
Outcome results
None listed