Acetic Acid for the Detection of Esophageal Neoplasms

Not Applicable

Suspended

• Conditions: Dysplasia; Intestinal Metaplasia; Barretts Esophagus With Low Grade Dysplasia

• Registration Number: NCT04054713
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-07-03
• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Confirmed histological diagnosis of intestinal metaplasia in follow-up protocol without dysplasia
• Patients whose endoscopic image is suggestive of esophageal intestinal metaplasia and is confirmed by histology
• Barrett's esophagus minimally 2cm
• Patients over 18 years of age who wish to participate in the study
• Signed informed consent

Exclusion Criteria

• Histological evidence of esophageal adenocarcinoma or known with dysplasia
• History of esophageal ablative therapy
• Known allergy or intolerance to proton pump inhibitors or acetic acid
• Evidence of esophageal varices
• Los Angeles esophagitis C or D
• Uncontrolled coagulopathy (INR> 1.5 or platelets <50,000)
• Pregnancy
• No authorization of informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Comparing the incidence of dysplasia by directed biopsies with acetic acid chromoendoscopy against taking non-directed protocolized biopsies( Seattle protocol) in patients with Barrett's esophagus.	After the wash out time of 6-8 weeks on PPI, this maneuver will be added	The second maneuver consist on taking non directed biopsies by the Seattle protocol in the same patient. And the incidence of dysplasia on biopsies will be looked for using Vienna Classification system again.

Trial Locations

Locations (1)

Centro Medico Nacional Siglo XXI Hospital de Especialidades; 🇲🇽 Mexico City, Mexico