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

NCT ID: NCT02867826

Last Updated: 2016-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Ampulla of Vater Intestinal-Type Adenoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cap-assisted endoscopy

forward-viewing endoscope with a Cap attached at the tip

Group Type EXPERIMENTAL

Cap

Intervention Type DEVICE

Cap-assisted endoscopy

Interventions

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Cap

Cap-assisted endoscopy

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Barretos Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Denise Peixoto Guimarães

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Denise P Guimarães, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Barretos Cancer Hospital

Locations

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Barretos Cancer Hospital

Barretos, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Denise P Guimarães, MD, PhD

Role: CONTACT

+551733216600

Facility Contacts

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Denise P Guimarães, MD, PhD

Role: primary

+55 17 33216600 ext. 6777

References

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Silva LC, Arruda RM, Botelho PFR, Taveira LN, Giardina KM, de Oliveira MA, Dias J, Oliveira CZ, Fava G, Guimaraes DP. Cap-assisted endoscopy increases ampulla of Vater visualization in high-risk patients. BMC Gastroenterol. 2020 Jul 9;20(1):214. doi: 10.1186/s12876-020-01361-5.

Reference Type DERIVED
PMID: 32646369 (View on PubMed)

Other Identifiers

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BarretosCH - 20161

Identifier Type: -

Identifier Source: org_study_id

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