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Acetic Acid for the Detection of Esophageal Neoplasms

Primary Purpose

Barretts Esophagus With Low Grade Dysplasia, Dysplasia, Intestinal Metaplasia

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Acetic acid chromoendoscopy
Seattle protocol
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Barretts Esophagus With Low Grade Dysplasia focused on measuring Barrett Esophagus, Dysplasia, acetic acid, Seattle protocol, Chromoendoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centro Medico Nacional Siglo XXI Hospital de EspecialidadesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Chromoendoscopy with acetic acid and targeted biopsies

Seattle protocol

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2019
Last Updated
July 21, 2022
Sponsor
Coordinación de Investigación en Salud, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT04054713
Brief Title
Acetic Acid for the Detection of Esophageal Neoplasms
Official Title
Acetic Acid vs Seattle Protocol for Neoplastic Lesions in Barrett Esophagus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barretts Esophagus With Low Grade Dysplasia, Dysplasia, Intestinal Metaplasia
Keywords
Barrett Esophagus, Dysplasia, acetic acid, Seattle protocol, Chromoendoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Participant
Masking Description
Participant will be initially allocated in either group without knowing its initial manoeuver
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chromoendoscopy with acetic acid and targeted biopsies
Arm Type
Active Comparator
Arm 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.
Arm Title
Seattle protocol
Arm Type
Active Comparator
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Acetic acid chromoendoscopy
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Seattle protocol
Intervention Description
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 Measure Information:
Title
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.
Description
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.
Time Frame
Patient will be on proton pump inhibitor (PP) for 6-8 weeks
Title
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.
Description
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.
Time Frame
After the wash out time of 6-8 weeks on PPI, this maneuver will be added

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oscar V Hernández Mondragón, MD
Phone
+525556276900
Ext
21317-8
Email
mondragonmd@yahoo.co.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Raul Alberto Gutiérrez Aguilar, Fellow
Phone
+525556276900
Ext
21317-8
Email
drgutierrezaguilar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar V Hernandez Mondragon, MD
Organizational Affiliation
IMSS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Medico Nacional Siglo XXI Hospital de Especialidades
City
Mexico City
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar V Hernández Mondragón, MD
Phone
+525556276900
Ext
21317-8
Email
mondragonmd@yahoo.co.uk
First Name & Middle Initial & Last Name & Degree
Raul Alberto Gutiérrez Aguilar, Fellow
Phone
+525556276900
Ext
21317-8
Email
drgutierrezaguilar@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23707461
Citation
Singh S, Sharma AN, Murad MH, Buttar NS, El-Serag HB, Katzka DA, Iyer PG. Central adiposity is associated with increased risk of esophageal inflammation, metaplasia, and adenocarcinoma: a systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2013 Nov;11(11):1399-1412.e7. doi: 10.1016/j.cgh.2013.05.009. Epub 2013 May 22.
Results Reference
background
PubMed Identifier
23318485
Citation
Rubenstein JH, Morgenstern H, Appelman H, Scheiman J, Schoenfeld P, McMahon LF Jr, Metko V, Near E, Kellenberg J, Kalish T, Inadomi JM. Prediction of Barrett's esophagus among men. Am J Gastroenterol. 2013 Mar;108(3):353-62. doi: 10.1038/ajg.2012.446. Epub 2013 Jan 15.
Results Reference
background
PubMed Identifier
16630761
Citation
Sharma P, Falk GW, Weston AP, Reker D, Johnston M, Sampliner RE. Dysplasia and cancer in a large multicenter cohort of patients with Barrett's esophagus. Clin Gastroenterol Hepatol. 2006 May;4(5):566-72. doi: 10.1016/j.cgh.2006.03.001. Epub 2006 Apr 17.
Results Reference
background
PubMed Identifier
26526079
Citation
Shaheen NJ, Falk GW, Iyer PG, Gerson LB; American College of Gastroenterology. ACG Clinical Guideline: Diagnosis and Management of Barrett's Esophagus. Am J Gastroenterol. 2016 Jan;111(1):30-50; quiz 51. doi: 10.1038/ajg.2015.322. Epub 2015 Nov 3. Erratum In: Am J Gastroenterol. 2016 Jul;111(7):1077.
Results Reference
background
PubMed Identifier
29340297
Citation
Chedgy F, Fogg C, Kandiah K, Barr H, Higgins B, McCord M, Dewey A, De Caestecker J, Gadeke L, Stokes C, Poller D, Longcroft-Wheaton G, Bhandari P. Acetic acid-guided biopsies in Barrett's surveillance for neoplasia detection versus non-targeted biopsies (Seattle protocol): A feasibility study for a randomized tandem endoscopy trial. The ABBA study. Endosc Int Open. 2018 Jan;6(1):E43-E50. doi: 10.1055/s-0043-120829. Epub 2018 Jan 12.
Results Reference
background
PubMed Identifier
28970288
Citation
Kandiah K, Chedgy FJQ, Subramaniam S, Longcroft-Wheaton G, Bassett P, Repici A, Sharma P, Pech O, Bhandari P. International development and validation of a classification system for the identification of Barrett's neoplasia using acetic acid chromoendoscopy: the Portsmouth acetic acid classification (PREDICT). Gut. 2018 Dec;67(12):2085-2091. doi: 10.1136/gutjnl-2017-314512. Epub 2017 Sep 28.
Results Reference
background
PubMed Identifier
24713305
Citation
Tholoor S, Bhattacharyya R, Tsagkournis O, Longcroft-Wheaton G, Bhandari P. Acetic acid chromoendoscopy in Barrett's esophagus surveillance is superior to the standardized random biopsy protocol: results from a large cohort study (with video). Gastrointest Endosc. 2014 Sep;80(3):417-24. doi: 10.1016/j.gie.2014.01.041. Epub 2014 Apr 6.
Results Reference
background

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Acetic Acid for the Detection of Esophageal Neoplasms

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