Risk study of pre-neoplastic lesions in the low esophagus
| ISRCTN | ISRCTN12753474 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12753474 |
| Secondary identifying numbers | 1.008.491 |
- Submission date
- 20/01/2019
- Registration date
- 13/02/2019
- Last edited
- 11/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Public
Av. Presidente Vargas 2355 - Policlínica Provedor Wilson Aita
Sala 1307 - 13º Andar
Santa Maria
97015-513
Brazil
Study information
| 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 | |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Risk study of pre-neoplastic lesions in differently-sized mucosa projections of columnar epithelium in the low esophagus |
| Study objectives | 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(s) | Instituto Universitário Italiano de Rosário's Bioethics Committee, 28/06/2016, ref. nro. 04/16. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 10/04/2015 |
| Completion date | 30/07/2017 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | At least 1000 |
| Key inclusion criteria | Request for upper gastrointestinal endoscopy |
| Key exclusion criteria | 1. Oesophageal obstruction 2. Post-oesophagectomy and bariatric surgery patients 3. Projections ≥3cm 4. Patients under 18 years of age |
| Date of first enrolment | 01/06/2015 |
| Date of final enrolment | 30/08/2016 |
Locations
Countries of recruitment
- Brazil
Study participating centres
Sala 1307 - 13º Andar
Santa Maria
97015-513
Brazil
Santa Maria
97045-060
Brazil
Santa Maria
97105-900
Brazil
Sponsor information
University/education
Gabinete de Ensino e Pesquisa
Av. Roraima nº 1000, Prédio 22
Térreo, próximo a Superintendência
Bairro Camobi, Cidade Universitária
Santa Maria
97105-900
Brazil
| Website | http://coral.ufsm.br/depe/ |
|---|---|
"ROR" |
https://ror.org/00aqfrr40 |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
Results and Publications
| Intention to publish date | 05/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | I want to publish my research papers in Journal of Gastroenterology as soon as possible |
| IPD sharing plan | 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. |
