Clinical trial NCT06029608: Evaluation of the Efficacy and Safety of Magnetically-controlled Capsule Gastroscopy for Postoperative Assessment in Elderly Patients and Patients With Underlying Diseases
Official title: Evaluation of the Efficacy and Safety of Magnetically-controlled Capsule Gastroscopy for Postoperative Assessment in Elderly Patients and Patients With Underlying Diseases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Evaluation,Efficacy,Safety
Keywords: Magnetically-controlled Capsule Endoscopy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

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.

Primary outcomes:
measure: Detection of gastric lesions (or postoperative complications)
timeFrame: 1 day
Secondary outcomes:
measure: Upper gastrointestinal discomfort symptoms or not
timeFrame: 1 day
measure: Patients' comfort during the procedure
timeFrame: 1 day
measure: Gastric clarity and visibility
timeFrame: 1 day
measure: Detection of small intestinal and colonic lesions in the magnetic-controlled capsule endoscopy group
timeFrame: 1 day
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
References: