An interventional study of Cap-EGD and Duo in Observation of Major Duodenal Papilla (MDP), sponsored by Air Force Military Medical University, China. Completed at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-10-22.
Sponsored by Air Force Military Medical University, China · Not applicable, Interventional, and Diagnostic
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.
Air Force Military Medical University, China is the lead sponsor of 172 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Undergoing cap-assisted esophagogastroduodenoscopy
Device: Cap-EGD
Undergoing side-viewing duodenoscope
Device: Duo
Undergoing cap-assisted endoscopy
Undergoing side-viewing duodenoscope
Rate of complete examination of MDP
Complete examination is defined by visualization of both proximal and distal ends with orifice of papilla
Time frame: 5 minutes after intubation of the esophagus
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)
Time frame: 5 minutes after intubation of the esophagus
Overall endoscopic findings
All pathological findings which are seen during the examination should be reported (e.g. reflux esophagitis, gastric cancer, gastric ulcer, duodenal ulcer, etc)
Time frame: 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)
Time frame: 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
Time frame: 5 minutes after intubation of the esophagus
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Air Force Military Medical University, China