Cap Assisted Forward-Viewing Endoscope vs Side-Viewing Endoscope for Examination of Major Duodenal Papilla
NCT ID: NCT02883608
Last Updated: 2017-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2016-08-31
2017-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Initial cap assisted endoscopy
undergo initial cap assisted forward-viewing endoscope then side-viewing duodenoscope
cap assisted forward-viewing endoscope
a cap fitted to the to top of the forward-viewing endoscope
Initial standard endoscopy
undergo initial side-viewing duodenoscope then cap assisted forward-viewing endoscope
cap assisted forward-viewing endoscope
a cap fitted to the to top of the forward-viewing endoscope
Interventions
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cap assisted forward-viewing endoscope
a cap fitted to the to top of the forward-viewing endoscope
Eligibility Criteria
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Inclusion Criteria
* age over 18 years
* ability to provide informed consent
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Technical University of Munich
OTHER
Responsible Party
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Mohamed Abdelhafez
Cap Assisted Forward-Viewing Endoscope vs Side-Viewing Endoscope for Examination of Major Duodenal Papilla
Locations
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II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, Germany
Countries
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References
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Abdelhafez M, Phillip V, Hapfelmeier A, Sturm V, Elnegouly M, Dollhopf M, Kassem A, Klare P, Nennstiel S, Schmid RM, von Delius S, Eckel F. Comparison of cap-assisted endoscopy vs. side-viewing endoscopy for examination of the major duodenal papilla: a randomized, controlled, noninferiority crossover study. Endoscopy. 2019 May;51(5):419-426. doi: 10.1055/a-0662-5445. Epub 2018 Sep 10.
Other Identifiers
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216/16 s
Identifier Type: -
Identifier Source: org_study_id
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