Clinical trial NCT04054713: Acetic Acid for the Detection of Esophageal Neoplasms
Official title: Acetic Acid vs Seattle Protocol for Neoplastic Lesions in Barrett Esophagus
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Barretts Esophagus With Low Grade Dysplasia
Dysplasia
Intestinal Metaplasia
Keywords: Barrett Esophagus
Dysplasia
acetic acid
Seattle protocol
Chromoendoscopy
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2019-08-13
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: 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.
timeFrame: Patient will be on proton pump inhibitor (PP) for 6-8 weeks
measure: 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.
timeFrame: After the wash out time of 6-8 weeks on PPI, this maneuver will be added
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Centro Medico Nacional Siglo XXI Hospital de Especialidades
Study officials:
affiliation: IMSS
name: Oscar V Hernandez Mondragon, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.