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Examination of major duodenal papilla (MDP) using a side-viewing duodenoscope is a golden standard. However, side-viewing duodenoscope is not available in some endoscopic centers. Cap-assisted esophagogastroduodenoscopy (Ca-EGD) using a transparent cap fitted to the tip of the scope has emerged as an alternative method for the observation of MDP. A recent study showed that complete examination of MDP could be achieved in 97% of patients. The investigators hypothesize that Ca-EGD is non-inferior to duodenoscope for the observation of MDP.
Interim analyses were planned to be performed by the data and safety monitoring board after data collection has been completed for 50% of the enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cap group: Cap-EGD | Experimental | Undergoing cap-assisted esophagogastroduodenoscopy |
|
| Duo group: Duo | Active Comparator | Undergoing side-viewing duodenoscope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cap-EGD | Device | Undergoing cap-assisted endoscopy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete examination of MDP | Complete examination is defined by visualization of both proximal and distal ends with orifice of papilla | 5 minutes after intubation of the esophagus |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic findings in descending duodenum | All pathological findings which are seen in descending duodenum should be reported (e.g. ampullary adenoma, peripapillary diverticulum, ampullary carcinoma, inflammatory change of papilla, etc) | 5 minutes after intubation of the esophagus |
| Overall endoscopic findings |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoscopic center, Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi | 710032 | China | ||
| Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30620948 | Derived | Shi X, Luo H, Ning B, Wang X, Tao Q, Liang S, Zhang R, Chen J, Luo B, Yao S, Pan Y, Guo X, Fan D. Effect of cap-assisted esophagogastroduodenoscopy on examination of the major duodenal papilla: a noninferior, randomized controlled trial. Endoscopy. 2019 May;51(5):427-435. doi: 10.1055/a-0767-6529. Epub 2019 Jan 8. |
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| Duo |
| Device |
Undergoing side-viewing duodenoscope |
|
All pathological findings which are seen during the examination should be reported (e.g. reflux esophagitis, gastric cancer, gastric ulcer, duodenal ulcer, etc) |
| 5 minutes after intubation of the esophagus |
| MDP examination time | The times taken for the examination of the MDP (after passing the pylorus until examination of MDP) | 5 minutes after intubation of the esophagus |
| MDP examination score | Score 3 when proximal end, distal end and orifice were visualized; Score 2 when either proximal or distal end with orifice were visualized; Score 1 when either proximal or distal end without orifice was visualized; Score 0 when the MDP could not be localized | 5 minutes after intubation of the esophagus |
| Chongqing |
| 400010 |
| China |