Observation of Major Duodenal Papilla (MDP)
Conditions
Brief 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.
Interventions
DEVICECap-EGD
Undergoing cap-assisted endoscopy
DEVICEDuo
Undergoing side-viewing duodenoscope
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years and \< 70 years * Patients with native MDP who underwent ERCP
Exclusion criteria
* Prior surgery in upper GI tract * Prior history of endoscopic sphincterotomy * Prior history of MDP treatment * Known or suspected obstruction of upper GI tract * Patients in poor condition who may not be suitable for Ca-EGD or duodenoscope * Pregnancy or lactic women * Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complete examination of MDP | 5 minutes after intubation of the esophagus | Complete examination is defined by visualization of both proximal and distal ends with orifice of papilla |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic findings in descending duodenum | 5 minutes after intubation of the esophagus | 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) |
| Overall endoscopic findings | 5 minutes after intubation of the esophagus | All pathological findings which are seen during the examination should be reported (e.g. reflux esophagitis, gastric cancer, gastric ulcer, duodenal ulcer, etc) |
| MDP examination time | 5 minutes after intubation of the esophagus | The times taken for the examination of the MDP (after passing the pylorus until examination of MDP) |
| MDP examination score | 5 minutes after intubation of the esophagus | 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 |
Countries
China
Outcome results
None listed