Cap Assisted Forward-Viewing Endoscope vs Side-Viewing Endoscope for Examination of Major Duodenal Papilla

Study Overview
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Brief Summary
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Examination of major duodenal papilla (MDP) using a standard forward-viewing esophagogastroduodenoscopy (S-EGD) is limited. Until now, side-viewing duodenoscope is the modality of choice to examine the MDP. Cap assisted esophagogastroduodenoscopy (CA-EGD) uses a cap fitted to the tip of the scope that can depress the mucosal folds and thus improve visualization and examination of MDP. The aim of this study is to compare CA-EGD to side*viewing duodenoscope for complete examination of MDP.

Official Title
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Cap Assisted Forward-Viewing Endoscope vs Side-Viewing Endoscope for Examination of Major Duodenal Papilla

Conditions
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Duodenal Papilla, Major

Intervention / Treatment
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* Procedure: cap assisted forward-viewing endoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indication for elective upper endoscopy age over 18 years ability to provide informed consent Exclusion Criteria: surgically altered upper gastrointestinal tract known or suspected upper gastrointestinal strictures upper gastrointestinal bleeding biliary stent planned endoscopic intervention American Society of Anesthesiologists class III or higher contraindication for or refusal of sedation with Propofol inability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Initial cap assisted endoscopy<br>undergo initial cap assisted forward-viewing endoscope then side-viewing duodenoscope | Procedure: cap assisted forward-viewing endoscope<br>* a cap fitted to the to top of the forward-viewing endoscope<br>|
| Active Comparator: Initial standard endoscopy<br>undergo initial side-viewing duodenoscope then cap assisted forward-viewing endoscope | Procedure: cap assisted forward-viewing endoscope<br>* a cap fitted to the to top of the forward-viewing endoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete visualisation of papilla duodeni major | complete visualization is defined by visualization of both proximal and distal ends together with the orifice of the papilla | within 5 minutes after intubation of the esophagus | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration needed to localize the papilla |  | within 5 minutes after intubation of the esophagus | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Papilla, major duodenal papilla, ampulla of vater