MCE: Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MCE patients were assigned to swallow MCE first, followed by the gastroscopy |
Device: MCE
Other Names:
|
| Active Comparator: Standard gastroscopy patients were assigned to swallow MCE first, followed by the gastroscopy |
Device: Standard gastroscopy
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients presented with gastric symptoms and ready for the first Upper GI endoscopy
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Patients with known focal gastric diseases: gastric ulcer, gastric polyps, early gastric cancer, gastric stromal tumors and so on.
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Age of 18 years to 70 years
Exclusion Criteria:
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Patients with impaired bowel movement from ileus or organic digestive diseases
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Patients with known large and obstructing tumors of the upper GI tract
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Patients after upper GI surgery or abdominal surgery altering GI anatomy
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Patients under full anticoagulation
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Patient in poor general condition
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Patients using equipment that may be affected by radio transmission
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Patients using equipment that may be affected by magnetic field
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Pregnancy or suspected pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Changhai Hospital | Shanghai | China | 200433 |
Sponsors and Collaborators
- Changhai Hospital
- RenJi Hospital
- Nanfang Hospital of Southern Medical University
- Chinese PLA General Hospital
- General Hospital of Beijing PLA Military Region
- Wuhan Union Hospital, China
- Shandong Provincial Hospital
- Peking Union Medical College Hospital
Investigators
- Principal Investigator: Zhaoshen Li, Prof., Changhai Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Liao Z, Duan XD, Xin L, Bo LM, Wang XH, Xiao GH, Hu LH, Zhuang SL, Li ZS. Feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers. J Interv Gastroenterol. 2012 Oct-Dec;2(4):155-160. doi: 10.4161/jig.23751. Epub 2012 Oct 1.
- Liao Z, Gao R, Xu C, Li ZS. Indications and detection, completion, and retention rates of small-bowel capsule endoscopy: a systematic review. Gastrointest Endosc. 2010 Feb;71(2):280-6. doi: 10.1016/j.gie.2009.09.031. Review.
- MCE-1