Cap Assisted Upper Endoscopy to Visualize the Major Duodenal Papilla (Kappa-I)

Technical University of Munich

Status: Completed

Conditions: Visualisation and Evaluation of Ampulla of Vater

Treatments: Device: Cap

Study type: Interventional

Funder types: Other

Identifiers

NCT02877797

14/16S

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

standard Esophagogastroduodenoscopy

No Intervention group

Description:

standard Esophagogastroduodenoscopy

cap assisted Esophagogastroduodenoscopy

Experimental group

Description:

cap assisted Esophagogastroduodenoscopy

Treatment:

Device: Cap