Early Gastric Cancer,, Chronic Gastritis, Gastric Polyps,, Gastric Diseases,, Gastric Ulcer,
Conditions
Brief summary
A new Magnetic-controlled Capsule Endoscopy (MCE) was developed by ANKON and got SFDA's approval in China in 2013. It has recently been evaluated to compare the diagnostic accuracy of MCE with that of standard gastroscopy for gastric diseases in 70 patients with encouraging results (In Press). To further testify the diagnostic accuracy of MCE for both the diffuse and focal diseases in stomach, we performed this single-blinded multi-center prospective study compared MCE with gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.
Interventions
DEVICEMCE
DEVICEStandard gastroscopy
Sponsors
RenJi Hospital
Nanfang Hospital, Southern Medical University
Chinese PLA General Hospital
General Hospital of Beijing PLA Military Region
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Shandong Provincial Hospital
Peking Union Medical College Hospital
Changhai Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients presented with gastric symptoms and ready for the first Upper GI endoscopy * Patients with known focal gastric diseases: gastric ulcer, gastric polyps, early gastric cancer, gastric stromal tumors and so on. * Age of 18 years to 70 years
Exclusion criteria
* Patients with impaired bowel movement from ileus or organic digestive diseases * Patients with known large and obstructing tumors of the upper GI tract * Patients after upper GI surgery or abdominal surgery altering GI anatomy * Patients under full anticoagulation * Patient in poor general condition * Patients using equipment that may be affected by radio transmission * Patients using equipment that may be affected by magnetic field * Pregnancy or suspected pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects diagnosed with gastric diffuse lesions by MCE Versus Standard Gastroscopy | 2 days |
| Number of gastric focal lesions founded by MCE Versus Standard Gastroscopy | 2 days |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients in whom there was complete visualization of the gastric surface in the antrum, body, and fundus and identification of the cardia and pylorus | 1 day |
| Examination times of MCE and standard gastroscopy | 1 day |
| Volume of water and drugs used for gastric preparation | 1 hour |
| Adverse events of both procedures | 2 weeks |
| Patient acceptance of MCE and standard gastroscopy | 3 days |
| Scores of the cleanliness of stomach after preparation | 1 day |
Countries
China
Outcome results
None listed