Ampulla of Vater Intestinal-Type Adenoma
Conditions
Keywords
Endoscopy, Ampulla of Vater, Duodenoscopy
Brief summary
The aim of this study is to compare the visualization rates of the ampulla of Vater using forward- viewing endoscopes with or without cap attached to the distal end in the same patient.
Detailed description
The complete visualization of the ampulla of Vater for the detection of ampullary neoplastic lesions is technically challenging with a forward-viewing endoscope. There are limited data in the relevant literature regarding the effectiveness of the Cap assisted forward viewing endoscope for accurate evaluation of the ampulla de Vater. Therefore, the aim of this study is to compare the visualization rates of the ampulla of Vater using forward-viewing endoscopes with or without cap attached to the distal end in the same patient.
Interventions
DEVICECap
Cap-assisted endoscopy
Sponsors
Barretos Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Cap-assisted endoscopy * Referral to endoscopic examination of ampulla of Vater
Exclusion criteria
* Patients with surgically modified anatomy. * Obstruction of the upper gastrointestinal tract. * Contra-indication for endoscopy. * Absence of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visualization rates of the ampulla of Vater | Up to 30 minutes during gastrointestinal endoscopy |
Secondary
| Measure | Time frame |
|---|---|
| Rates of complications for both groups. | Up to 3 hours after upper endoscopy |
| Additional time required for Cap-assisted endoscopy | Up to 30 minutes during upper endoscopy |
| Need for additional sedation required for the Cap-assisted endoscopy. | Up to 30 minutes during upper endoscopy |
Countries
Brazil
Contacts
Primary ContactDenise P Guimarães, MD, PhD
Outcome results
None listed