NCT03219619

Effect of Cap-assisted Esophagogastroduodenoscopy on Observation of Major Duodenal Papilla

Effect of Cap-assisted Esophagogastroduodenoscopy on Observation of Major Duodenal Papilla: a Randomized Non-inferiority Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Air Force Military Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Observation of Major Duodenal Papilla (MDP)

Interventions

Type	Name	Description
DEVICE	Cap-EGD	Undergoing cap-assisted endoscopy
DEVICE	Duo	Undergoing side-viewing duodenoscope

Timeline

• Start date: 2018-07-20
• Primary completion: 2018-07-20
• Completion: 2018-07-20
• First posted: 2017-07-17
• Last updated: 2019-10-22

Locations

2 sites across 1 country: China