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

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ClinicalTrials.gov Identifier: NCT02867826
Recruitment Status : Unknown
Verified August 2016 by Denise Peixoto Guimarães, Barretos Cancer Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 16, 2016
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
Denise Peixoto Guimarães, 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.

Condition or disease Intervention/treatment Phase
Ampulla of Vater Intestinal-Type Adenoma Device: Cap Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Use of Cap-assisted Forward Viewing Endoscopy for Examination of the Ampulla of Vater
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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




Primary Outcome Measures :
  1. Visualization rates of the ampulla of Vater [ Time Frame: Up to 30 minutes during gastrointestinal endoscopy ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867826


Contacts
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Contact: Denise P Guimarães, MD, PhD +551733216600 guimaraes.dp@gmail.com

Locations
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Brazil
Barretos Cancer Hospital Not yet recruiting
Barretos, São Paulo, Brazil, 14784400
Contact: Denise P Guimarães, MD, PhD    +55 17 33216600 ext 6777    guimaraes.dp@gmail.com   
Principal Investigator: Denise P Guimarães, MD, PhD         
Sub-Investigator: Leonardo C Silva, MD         
Sponsors and Collaborators
Barretos Cancer Hospital
Investigators
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Principal Investigator: Denise P Guimarães, MD, PhD Barretos Cancer Hospital

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Responsible Party: Denise Peixoto Guimarães, Principal Investigator, Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT02867826     History of Changes
Other Study ID Numbers: BarretosCH - 20161
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Denise Peixoto Guimarães, Barretos Cancer Hospital:
Endoscopy
Ampulla of Vater
Duodenoscopy

Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms