Condition category
Cancer
Date applied
20/01/2019
Date assigned
13/02/2019
Last edited
11/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Barrett’s esophagus is an acquired condition that predisposes to the development of esophageal adenocarcinoma. The main objective of this research was to establish an association between the endoscopic and the histopathological findings regarding differently sized endoscopic columnar epithelial mucosa projections in the low esophagus, under 3.0 centimeters in longitudinal extent.

Who can participate?
All patients coming in with a request for upper gastrointestinal endoscopy, regardless of the clinical indication.

What does the study involve?
Upper gastrointestinal endoscopy followed by a biopsy.

What are the possible benefits and risks of participating?
The benefits and risks of participating are the same of gastrointestinal endoscopy.

Where is the study run from?
Clínica Cirúrgica do Aparelho Digestivo, Clínica de Endoscopia do Hospital Casa de Saúde and Serviço de Endoscopia da Unidade de Cirurgia Digestiva do Hospital Universitário de Santa Maria, in Santa Maria, RS, Brazil

When is the study starting and how long is it expected to run for?
July 2015 to June 2017.

Who is funding the study?
Hospital Universitário de Santa Maria and investigator initiated and funded.

Who is the main contact?
Hairton Copetti
hairtoncopetti@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Mr Hairton Copetti

ORCID ID

Contact details

Av. Presidente Vargas 2355 - Policlínica Provedor Wilson Aita
Sala 1307 - 13º Andar
Santa Maria
97015-513
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.008.491

Study information

Scientific title

Risk study of pre-neoplastic lesions in differently-sized mucosa projections of columnar epithelium in the low esophagus

Acronym

Study hypothesis

Establish an association between the endoscopic and the histopathological findings regarding differently sized endoscopic columnar epithelial mucosa projections in the low esophagus, under 3.0 centimeters in longitudinal extent

Ethics approval

Instituto Universitário Italiano de Rosário's Bioethics Committee, 28/06/2016, ref. nro. 04/16.

Study design

Prospective, experimental study, of diagnostic investigation, by a series of consecutive cases in three different locations

Primary study design

Other

Secondary study design

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Progression of Barrett's esophagus to adenocarcinoma

Intervention

All consecutive patients coming in with a request for upper gastrointestinal endoscopy were included, regardless of the clinical indication, between April/2015 and August/2016.

In performing the exams, habitual technique for upper gastrointestinal endoscopies was followed: suspicious areas were identified by mucosa projection, from the top of the gastric folds to the columnar mucosa, more reddish and vascularized in the low esophagus. At this moment, insufflation was diminished for better identification of the gastric folds. Then, a 1.5% application of acetic acid was used for coloring. Once the suspicious area was identified, a previously laser-graded biopsy clamp with 0.5 cm intervals, designed by the author, was introduced through the gastroscope working canal; the projection was measured and then biopsies were performed following the Seattle Protocol (Figs. 3, 4, 5, 6 and 7).

The observation time was during the exam. There was no follow-up.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Diagnosis of Barrett's esophagus was determined using upper gastrointestinal endoscopy to detect the presence of columnar mucosa in the esophagus in the shape of digitiform projections, or segments that cover the circumference of the esophagus partially or totally.

Secondary outcome measures

1. The number of suspected lesions was determined using upper gastrointestinal endoscopy.
2. The size of suspected lesions was measured using previously laser-graded biopsy clamp with 0.5cm intervals, designed by the author, and divided in three groups of interes: Group 1 - projections up to 0.99cm, group 2 - 1.00 to 1.99cm and group 3 - 2.00 to 2.99cm, and then biopsied following the Seattle Protocol.
3. The number of suspected lesions during endoscopic examination was 81, where 59 subjects (72.8%) did not confirm for Barrett's esophagus after histologic exam, and 22 (27.2%) were confirmed, representing 1.74% of sample total

Overall trial start date

10/04/2015

Overall trial end date

30/07/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Request for upper gastrointestinal endoscopy

Participant type

Other

Age group

All

Gender

Both

Target number of participants

At least 1000

Participant exclusion criteria

1. Oesophageal obstruction
2. Post-oesophagectomy and bariatric surgery patients
3. Projections ≥3cm
4. Patients under 18 years of age

Recruitment start date

01/06/2015

Recruitment end date

30/08/2016

Locations

Countries of recruitment

Brazil

Trial participating centre

Clínica Cirúrgica do Aparelho Digestivo
Av. Presidente Vargas 2355 - Policlínica Provedor Wilson Aita Sala 1307 - 13º Andar
Santa Maria
97015-513
Brazil

Trial participating centre

Clínica de Endoscopia do Hospital Casa de Saúde
Rua Ary Lagranha Domingues, 188 - Perpétuo Socorro
Santa Maria
97045-060
Brazil

Trial participating centre

Serviço de Endoscopia da Unidade de Cirurgia Digestiva do Hospital Universitário de Santa Maria
Av. Roraima 1000, Prédio 22, Campus, Bairro Camobi
Santa Maria
97105-900
Brazil

Sponsor information

Organisation

Hospital Universitário de Santa Maria

Sponsor details

Gabinete de Ensino e Pesquisa
Av. Roraima nº 1000
Prédio 22
Térreo
próximo a Superintendência
Bairro Camobi
Cidade Universitária
Santa Maria
97105-900
Brazil

Sponsor type

University/education

Website

http://coral.ufsm.br/depe/

Funders

Funder type

Hospital/treatment centre

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hospital Universitário de Santa Maria

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

I want to publish my research papers in Journal of Gastroenterology as soon as possible

IPD sharing statement: the datasets generated during and/or analysed during the current study are/will be available upon request from Hairton Copetti, hairtoncopetti@gmail.com, the files will be stored in a personal computer, in the researcher's office, protected by password, only avaliable upon request, and will be shared according to the terms of our consent from participants. The files will be stored for five years.

Intention to publish date

05/04/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes