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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Evaluation,Efficacy,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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Hui-Min H Chen, MD; Phone Number: 02168383015; Email: chenhuimin@renji.com

Study Locations

• China
  • Shanghai, China, 200001
    • Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Elderly patients (older than 65 years) and patients with underlying diseases (cardiovascular, respiratory, hemorrhagic diseases, etc.) who underwent surgery for gastric malignant tumors (including surgical resection and ESD).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Magnetically-controlled Capsule endoscopy group; Using magnetic-controlled capsule gastroscopy for postoperative assessment in elderly patients and patients with underlying diseases
Conventional endoscopy group; Using conventional endoscopy for postoperative assessment in elderly patients and patients with underlying diseases

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): September 6, 2023
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Magnetically-controlled Capsule Endoscopy
• Other Study ID Numbers: Renji202302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No