Acetic Acid for the Detection of Esophageal Neoplasms
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Barrett's Esophagus With Low Grade Dysplasia
- Dysplasia
- Intestinal Metaplasia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: 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 randomized into two groups, one of acetic acid and the other of the Seattle protocol as a method Initially and subsequently, a second endoscopy will be performed with the opposite method and the histopathological results of both groups will be compared.Masking: Single (Participant)Masking Description: Participant will be initially allocated in either group without knowing its initial manoeuverPrimary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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). Chromoendosco...
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.
Tracking Information
- NCT #
- NCT04054713
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Oscar V Hernandez Mondragon, MD IMSS