Acetic Acid for the Detection of Esophageal Neoplasms

Coordinación de Investigación en Salud, Mexico

Status: Suspended

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

Treatments: Diagnostic Test: Acetic acid chromoendoscopy; Diagnostic Test: Seattle protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04054713

R-2019-3601-143

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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76 participants in 2 patient groups

Chromoendoscopy with acetic acid and targeted biopsies

Active Comparator group

Description:

Acetic acid is prepared at a concentration of 2.5%, after initial cleaning is done, it will be applied with a 7 French spray catheter, starting the proximal application performing a uniform application on the area of intestinal metaplasia an then will be timed for mucous visualization in search of areas of loss of acetowhitening, in case of finding such area will be registered the time in which there was loss of acetowhitening, the distance at which it is located from the upper dental arch in addition to the esophageal face on which the area is located, subsequently evaluation of the glandular pattern is performed only by classifying as normal (glands evenly distributed with normal or abnormal crypt density (compact crypts with increased density; focal irregularity or disorganized crypts; absence of a cryptic pattern), once this evaluation has been carried out, biopsies are directed to these areas to be sent to the pathology service.

Treatment:

Diagnostic Test: Acetic acid chromoendoscopy

Seattle protocol

Active Comparator group

Description:

Take random biopsies by quadrants every 2 centimeters biopsy of the intestinal metaplasia areas 1cm above the esophagogastric junction begins, taking tissue every 2cm from the 4 quadrants, separating the biopsies in different bottles based on the length in which they were taken, to later be sent to the pathology service.

Treatment:

Diagnostic Test: Seattle protocol