SuspendedNot Applicable

Acetic Acid for the Detection of Esophageal Neoplasms

Stopped: not enough patients enrolled

Mexico76 participantsStarted 2019-07-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: Patient will be on proton pump inhibitor (PP) for 6-8 weeks

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.

Timeframe: After the wash out time of 6-8 weeks on PPI, this maneuver will be added

Trial details

NCT IDNCT04054713

SponsorCoordinación de Investigación en Salud, Mexico

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-05-01

View on ClinicalTrials.gov More Barretts Esophagus With Low Grade Dysplasia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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.

Timeframe: Patient will be on proton pump inhibitor (PP) for 6-8 weeks

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.

Timeframe: After the wash out time of 6-8 weeks on PPI, this maneuver will be added