The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater

Barretos Cancer Hospital

Status and phase: Unknown; Phase 2

Conditions: Ampulla of Vater Intestinal-Type Adenoma

Treatments: Device: Cap

Study type: Interventional

Funder types: Other

Identifiers

NCT02867826

BarretosCH - 20161

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Cap-assisted endoscopy

Experimental group

Description:

forward-viewing endoscope with a Cap attached at the tip

Treatment:

Device: Cap