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

Phase 2

• Conditions: Ampulla of Vater Intestinal-Type Adenoma
• Interventions: Device: Cap

• Registration Number: NCT02867826
• Lead Sponsor: Barretos Cancer Hospital

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.

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Study First Submitted: 2016-08-08
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-16
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-08-18
• Primary Completion: 2017-08
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cap-assisted endoscopy	Cap	forward-viewing endoscope with a Cap attached at the tip

Primary Outcome Measures

Name	Time	Method
Visualization rates of the ampulla of Vater	Up to 30 minutes during gastrointestinal endoscopy

Secondary Outcome Measures

Name	Time	Method
Rates of complications for both groups.	Up to 3 hours after upper endoscopy
Need for additional sedation required for the Cap-assisted endoscopy.	Up to 30 minutes during upper endoscopy
Additional time required for Cap-assisted endoscopy	Up to 30 minutes during upper endoscopy

Trial Locations

Locations (1)

Barretos Cancer Hospital; 🇧🇷 Barretos, São Paulo, Brazil