Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases

Study Overview
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Brief Summary
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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.

Official Title
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Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases: A Prospective Self-controlled Comparative Multicenter Trial

Conditions
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Gastric Diseases,, Gastric Ulcer,, Gastric Polyps,, Early Gastric Cancer,, Chronic Gastritis

Intervention / Treatment
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* Device: MCE
* Device: Standard gastroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCE<br>patients were assigned to swallow MCE first, followed by the gastroscopy | Device: MCE<br> <br> * Other names: magnetic-controlled capsule endoscopy;|
| Active Comparator: Standard gastroscopy<br>patients were assigned to swallow MCE first, followed by the gastroscopy | Device: Standard gastroscopy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of water and drugs used for gastric preparation |  | 1 hour | 
| Scores of the cleanliness of stomach after preparation |  | 1 day | 
| 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 | 
| Patient acceptance of MCE and standard gastroscopy |  | 3 days | 
| Adverse events of both procedures |  | 2 weeks |