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

August 17, 2016 updated by: Denise Peixoto Guimarães, Barretos Cancer Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784400
        • Barretos Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Denise P Guimarães, MD, PhD
        • Sub-Investigator:
          • Leonardo C Silva, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cap-assisted endoscopy
forward-viewing endoscope with a Cap attached at the tip
Device: Cap
Cap-assisted endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visualization rates of the ampulla of Vater
Time Frame: Up to 30 minutes during gastrointestinal endoscopy
Up to 30 minutes during gastrointestinal endoscopy

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barretos Cancer Hospital

Investigators

  • Principal Investigator: Denise P Guimarães, MD, PhD, Barretos Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

August 8, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Estimate)

August 18, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BarretosCH - 20161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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