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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Observation of Major Duodenal Papilla (MDP)

Intervention / Treatment
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* Device: Cap-EGD
* Device: Duo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cap group: Cap-EGD<br>Undergoing cap-assisted esophagogastroduodenoscopy | Device: Cap-EGD<br>* Undergoing cap-assisted endoscopy<br>|
| Active Comparator: Duo group: Duo<br>Undergoing side-viewing duodenoscope | Device: Duo<br>* Undergoing side-viewing duodenoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |