Evaluation of the Efficacy and Safety of Magnetically-controlled Capsule Gastroscopy for Postoperative Assessment in Elderly Patients and Patients With Underlying Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Evaluation,Efficacy,Safety. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Detection of gastric lesions (or postoperative complications) [Time frame: 1 day]
Secondary outcome measures (4)
- Upper gastrointestinal discomfort symptoms or not [Time frame: 1 day]
- Patients' comfort during the procedure [Time frame: 1 day]
- Gastric clarity and visibility [Time frame: 1 day]
- Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group [Time frame: 1 day]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai — Shanghai
Identifiers
NCT: NCT06029608 · Renji202302