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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| Chinese PLA General Hospital | OTHER |
| General Hospital of Beijing PLA Military Region |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCE | Experimental | patients were assigned to swallow MCE first, followed by the gastroscopy |
|
| Standard gastroscopy | Active Comparator | patients were assigned to swallow MCE first, followed by the gastroscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCE | Device |
|
| |
| Standard gastroscopy |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhaoshen Li, Prof. | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changhai Hospital | Shanghai | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23687601 | Background | 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. | |
| 20152309 | Background |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D013276 | Stomach Ulcer |
| C562464 | Polyposis, Gastric |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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| OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Peking Union Medical College Hospital | OTHER |
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| Device |
|
| 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 |
| 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. |
| 27211503 | Derived | Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20. |
| D007410 |
| Intestinal Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D013514 | Surgical Procedures, Operative |