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Trial record 13 of 16 for:    CFC1

Acetic Acid for the Detection of Esophageal Neoplasms

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ClinicalTrials.gov Identifier: NCT04054713
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Barretts Esophagus With Low Grade Dysplasia Dysplasia Intestinal Metaplasia Diagnostic Test: Acetic acid chromoendoscopy Diagnostic Test: Seattle protocol Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 manoeuver
Primary Purpose: Diagnostic
Official Title: Acetic Acid vs Seattle Protocol for Neoplastic Lesions in Barrett Esophagus
Actual Study Start Date : July 3, 2019
Estimated Primary Completion Date : December 3, 2019
Estimated Study Completion Date : July 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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.
Diagnostic Test: Acetic acid chromoendoscopy
Acetic acid is prepared at a concentration of 2.5% in a 20ml syringe, it will be applied with a 7 french spray catheter compatible with a working channel 2.8mm onwards, starting the proximal application When distally performing a uniform application on the area of intestinal metaplasia and the timed time for mucous visualization in search of areas of loss of acetowhitening begins, 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 face on which the area is located, subsequently evaluation of the glandular pattern is performed only by classifying as normal or abnormal, 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.
Diagnostic Test: Seattle protocol
Take random biopsies by quadrants every 2 centimeters. Biopsy of the intestinal metaplasia areas 1cm above the esophagogastric junction will be initiated, taking tissue every 2cm from the four quadrants, separating the biopsies in different bottles based on the length in which they were taken, to later be sent to the pathology service.




Primary Outcome Measures :
  1. 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. [ Time Frame: Patient will be on proton pump inhibitor (PP) for 6-8 weeks ]
    First the investigators will detect the incidence of dysplasia in Barrett esophagus in patients with acetic acid chromoendoscopy, using the Vienna Classification system by the pathologist.

  2. 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. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054713


Contacts
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Contact: Oscar V Hernández Mondragón, MD +525556276900 ext 21317-8 mondragonmd@yahoo.co.uk
Contact: Raul Alberto Gutiérrez Aguilar, Fellow +525556276900 ext 21317-8 drgutierrezaguilar@gmail.com

Locations
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Mexico
Centro Medico Nacional Siglo XXI Hospital de Especialidades Recruiting
Mexico City, Mexico, 06700
Contact: Oscar V Hernández Mondragón, MD    +525556276900 ext 21317-8    mondragonmd@yahoo.co.uk   
Contact: Raul Alberto Gutiérrez Aguilar, Fellow    +525556276900 ext 21317-8    drgutierrezaguilar@gmail.com   
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
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Principal Investigator: Oscar V Hernandez Mondragon, MD IMSS

Publications:

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Responsible Party: Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT04054713     History of Changes
Other Study ID Numbers: R-2019-3601-143
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Coordinación de Investigación en Salud, Mexico:
Barrett Esophagus
Dysplasia
acetic acid
Seattle protocol
Chromoendoscopy
Additional relevant MeSH terms:
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Barrett Esophagus
Hyperplasia
Metaplasia
Pathologic Processes
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Acetic Acid
Retinol acetate
Anti-Bacterial Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents