Acetic Acid for the Detection of Esophageal Neoplasms

Intestinal Metaplasia Clinical Trial

Official title:

Acetic Acid vs Seattle Protocol for Neoplastic Lesions in Barrett Esophagus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04054713
• Other study ID #: R-2019-3601-143
• Status: Recruiting
• Phase: N/A
• Start date: July 3, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2022
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: Oscar V Hernández Mondragón, MD
• Phone: +525556276900
• Email: mondragonmd[@]yahoo.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Barretts Esophagus With Low Grade Dysplasia
• Dysplasia
• Hyperplasia
• Intestinal Metaplasia
• Metaplasia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Mexico	Centro Medico Nacional Siglo XXI Hospital de Especialidades	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. Epub 2006 Apr 17. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Patient will be on proton pump inhibitor (PP) for 6-8 weeks
Primary	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.	After the wash out time of 6-8 weeks on PPI, this maneuver will be added