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| Name | Class |
|---|---|
| Second Military Medical University | OTHER |
| Ministry of Education, China | OTHER_GOV |
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Capsule endoscopy has been shown to be the first-line endoscopic procedure for small bowel disease. This study was aimed to compare the performance between the frequency-altering AKE-1 capsule and the Pillcam SB2 in patients with suspected small bowel disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pillcam SB2 first | Experimental | patients were assigned to swallow PSB first, followed by the AKE |
|
| AKE-1 first | Experimental | patients were assigned to swallow AKE first, followed by the PSB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AKE-1 | Device |
| ||
| Pillcam SB2 |
| Measure | Description | Time Frame |
|---|---|---|
| judgement of normal or abnormal of gastrointestinal tract | If a lesion is detected by capsule endoscopy in gastrointestinal tract in a patient, the result will be judged as abnormal. | 5 weeks after the examination |
| Measure | Description | Time Frame |
|---|---|---|
| complete small-bowel examination rate | 5 weeks after the examination | |
| diagnostic yield | The finding that could explain the symptom and resulted in clinical impact was considered as diagnosis.Diagnostic yield of a capsule endoscopy is the proportion of patients with positive diagnosis over total patients. |
| Measure | Description | Time Frame |
|---|---|---|
| number of adverse events as a measure of safety | 2 months after the examination |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhao-Shen Li, Dr. | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Union Hospital | Wuhan | Hubei | 430022 | China | ||
| Shanghai Changhai Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20152309 | Background | 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. | |
| 18410941 | Background | Cave DR, Fleischer DE, Leighton JA, Faigel DO, Heigh RI, Sharma VK, Gostout CJ, Rajan E, Mergener K, Foley A, Lee M, Bhattacharya K. A multicenter randomized comparison of the Endocapsule and the Pillcam SB. Gastrointest Endosc. 2008 Sep;68(3):487-94. doi: 10.1016/j.gie.2007.12.037. Epub 2008 Apr 14. |
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| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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|
| 5 weeks after the examination |
| total recording time | 5 weeks after the examination |
| gastric transit time | the comparison was completed 5 weeks after the examination |
| small-bowel transit time | the comparison was completed 5 weeks after the examination |
| total number of images captured | the comparison was completed 5 weeks after the examination |
| Shanghai |
| Shanghai Municipality |
| 200433 |
| China |
| 22930176 | Background | Dolak W, Kulnigg-Dabsch S, Evstatiev R, Gasche C, Trauner M, Puspok A. A randomized head-to-head study of small-bowel imaging comparing MiroCam and EndoCapsule. Endoscopy. 2012 Nov;44(11):1012-20. doi: 10.1055/s-0032-1310158. Epub 2012 Aug 28. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |