Acetic Acid vs Seattle Protocol for Neoplastic Lesions in Barrett Esophagus

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic Test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
Mexico
Centro Medico Nacional Siglo XXI Hospital de Especialidades
Recruiting
Mexico City
Contact Information
Primary
Oscar V Hernández Mondragón, MD
mondragonmd@yahoo.co.uk
+525556276900
Backup
Raul Alberto Gutiérrez Aguilar, Fellow
drgutierrezaguilar@gmail.com
+525556276900
Time Frame
Start Date: July 3, 2019
Estimated Completion Date: December 1, 2022
Participants
Target number of participants: 76
Treatments
Active Comparator: Chromoendoscopy with acetic acid and targeted biopsies
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.
Active Comparator: Seattle protocol
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.
Authors
Oscar V Hernandez Mondragon
Related Therapeutic Areas
Sponsors
Leads: Coordinación de Investigación en Salud, Mexico

This content was sourced from clinicaltrials.gov

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