Cap Assisted Upper Endoscopy to Visualize the Major Duodenal Papilla

NCT02877797 — Not applicable, Completed, 101 participants, Technical University of Munich

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The Use of Cap Assisted Forward Viewing Esophagogastroduodenoscopy to Examine the Major Duodenal Papilla

Registry	NCT02877797, acronym Kappa-I
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, diagnostic
Enrollment	101 (Actual)
Sponsor	Technical University of Munich (Other)
Conditions	Visualisation and Evaluation of Ampulla of Vater
Interventions	Cap (Device)
Dates	start 2016-02-01, primary completion 2016-05-01, completion 2016-08-01, first posted 2016-08-24, last updated 2016-08-24
Locations	1 site in Germany

-Summary

Aim of the present study is the evaluation of the diagnostic value of a cap assisted upper GI-endoscopy compared to a standard upper GI-endoscopy regarding the visualisation and evaluation of the papilla duodeni major.

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+Arms and interventions

Arm	Type	Interventions	Description
standard Esophagogastroduodenoscopy	No intervention		standard Esophagogastroduodenoscopy
cap assisted Esophagogastroduodenoscopy	Experimental	Device: Cap	cap assisted Esophagogastroduodenoscopy

Cap (Device): cap assisted esophagogastroduodenoscopy

+Outcome measures

Primary outcomes

Rate of complete visualisation of papilla duodeni major [120 seconds]: visualisation: none, incomplete, complete

Secondary outcomes

Diagnostic yield in the upper GI-tract [up to 10 minutes]: All pathological findings which are seen during the examination should be reported (e.g. reflux esophagitis, Barret's esophagus, duodenal erosions, etc)
time of investigation [up to 10 minutes]: Duration of Esophagogastroduodenoscopy
complication rate [up to one week]: Any complications related to the examination within one week would be reported.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Indication of Esophagogastroduodenoscopy independent from the study
* Written informed
* Age ≥ 18 years

Exclusion Criteria:

* Absence of written informed consent
* Contraindication or absence of informed consent regarding sedation with Propofol
* Postoperativ changes of the upper GI-tract
* Intention of endoscopic intervention
* Suspicion of upper GI-bleeding
* Suspicion of stenosis of the esophagus
* Stent in the papilla duodeni major
* ASA (American Society of Anesthesiologists) classification ≥ 3

+Locations (1)

Facility	City	Country	Status
Klinikum rechts der Isar der Technischen Universität München	Munich, Bavaria	Germany

+Investigators

Stefan von Delius, Principal investigator, Technical University of Munich

My Notes

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