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

NCT ID: NCT06029608

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-06
• Study Completion Date: 2026-10-30

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.

Conditions

Evaluation,Efficacy,Safety

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Magnetically-controlled Capsule endoscopy group

Using magnetic-controlled capsule gastroscopy for postoperative assessment in elderly patients and patients with underlying diseases

No interventions assigned to this group

Conventional endoscopy group

Using conventional endoscopy for postoperative assessment in elderly patients and patients with underlying diseases

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Xiaobo Li

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , China

Countries

China

Central Contacts

Hui-Min H Chen, MD

Role: CONTACT

chenhuimin@renji.com

02168383015

Other Identifiers

Renji202302

Identifier Type: -

Identifier Source: org_study_id