Acetic Acid for the Detection of Esophageal Neoplasms

Intestinal Metaplasia Clinical Trial

Official title: Acetic Acid vs Seattle Protocol for Neoplastic Lesions in Barrett Esophagus

Status Recruiting

Clinical Trial Summary

Barrett's esophagus is a complication of chronic gastroesophageal reflux disease that occurs in up to 10% to 15% of patients with this pathology. Well-defined risk factors have been established and are important because they are considered a precancerous lesion (intestinal metaplasia). The conventional diagnostic methods are ineffective in reliably detecting potentially treatable lesions. Investigators propose the use of vital chromoendoscopy with acetic acid using the simplified classification of Portsmouth looking for areas with loss of acetowhitening and taking targeted biopsies to increase the detection of esophageal neoplastic lesions.

Clinical Trial Description

Barrett's esophagus is a complication of chronic gastroesophageal reflux disease that occurs in up to 10 to 15% of patients with this disease, well-defined risk factors have been established and are important because they are considered a precancerous condition (metaplasia intestinal). Chromoendoscopy is postulated as an effective way for the detection of esophageal precancerous lesions, early detection and timely treatment with chromoendoscopy with acetic acid being a seemingly reliable alternative, so the investigators will use with the simplified classification of Portsmouth looking for areas with loss of acetowhitening and targeted biopsy to increase the detection of esophageal neoplastic lesions, our main objective being to compare the diagnostic effectiveness of directed biopsies of dysplastic lesions with acetic acid in patients with Barrett's esophagus compared to taking non-directed protocolized biopsies.

A clinical trial will be carried out, including all those patients older than 18 years who go to perform a superior endoscopy with diagnosis of Barrett's esophagus where patients will be up and B Seattle protocol group(four quadrant biopsy every 2 centimeters starting 1 centimeter from above the esophagogastric junction), then proton pump inhibitor washout and crossover allocation with the opposite corresponding manoeuver. Histopathological results of both groups will be compared.

Demographic data of the participants will be collected and the evaluated areas of Barrett's esophagus with each method will be recorded in a data collection sheet detailing in a specific way the number of biopsies taken, specifying if there was loss of acetowhitening and alterations in the mucous pattern and in the case of the opposite arm, the total number of biopsies taken based on the Seattle protocol, said data will be condensed into a database for subsequent statistical analysis and publication of results. ;

Related Conditions & MeSH terms

• Barrett Esophagus
• Barretts Esophagus With Low Grade Dysplasia
• Dysplasia
• Hyperplasia
• Intestinal Metaplasia
• Metaplasia

• NCT number: NCT04054713
• Study type: Interventional
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: Oscar V Hernández Mondragón, MD
• Phone: +525556276900
• Email: mondragonmd@yahoo.co.uk
• Status: Recruiting
• Phase: N/A
• Start date: July 3, 2019
• Completion date: December 1, 2022