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"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance

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ClinicalTrials.gov Identifier: NCT02614703
Recruitment Status : Recruiting
First Posted : November 25, 2015
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Ingrid Chacon, MD, Doctors Hospital at Renaissance

Brief Summary:
Neoplasia in Barrett's esophagus could be missed during routine random biopsies. We propose a study using chromoendoscopy with Acetic Acid to increase the yield of biopsies in detecting neoplasia.

Condition or disease Intervention/treatment Phase
Barrett's Esophagus Drug: Chromoendoscopy using Acetic Acid 2.5% Other: Standard random esophageal biopsies Phase 2 Phase 3

Detailed Description:

Neoplasia in Barrett's esophagus is often focal and can be missed by nontargeted biopsies alone. In recent years, various advanced endoscopic techniques have been utilized, but with varying success rates. Narrow-band imaging, trimodal imaging, spectral imaging and i-scan are technologies that are manufacturer dependent with limited varying success rates and have financial implications. At our institution, narrow band imaging is routinely utilized as a diagnostic tool for detecting Barrett's esophagus. Acetic acid is a commonly available dye that has been used in the detection of neoplasia in Barrett's esophagus.

This study is aimed to prove the effectiveness of acetic acid chromoendoscopy in our Barrett's esophagus surveillance population. The goal is to compare the neoplasia yield of acetic acid chromoendoscopy with that of standardized random biopsy protocol. The sensitivity and specificity for neoplasia detection by these two methods will also be analyzed.

Investigators plan to conduct this prospective randomized study for a period of one and a half years (beginning August 1, 2015, ending February 29, 2016). Based on data from 2014, we anticipate to enroll approximately 185 patients. All gastroenterologists (with privileges at Doctors Hospital at Renaissance) will participate in this study. Patients will be randomized to either acetic acid chromoendoscopy or current standard of care (standardized random biopsy protocol utilizing narrow band imaging). Random biopsies from both protocols and targeted biopsies (if identified) will be obtained and submitted to pathology department. These will be reviewed independently by two pathologists. Any discordant results will be reviewed by an outside expert pathologist. Statistical data analysis will be performed utilizing Datadesk XL software.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: "Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance is Superior to the Standardized Random Biopsy Protocol in Detecting Neoplasia: A Prospective Randomized Study"
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : September 13, 2018
Estimated Study Completion Date : December 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Chromoendoscopy using Acetic Acid 2.5%
Patient will have endoscopic examination of esophagus. Esophageal mucosa sprayed with 5cc solution of Acetic Acid 2.5% one time only. Esophageal mucosa examined again. Biopsies are obtained. Abnormal areas identified by Acetic Acid 2.5% will be submitted on separate containers for pathology review. If no abnormalities seen, random biopsies taken as per standard recommendations for Barrett's esophagus. Samples submitted for pathology review.
Drug: Chromoendoscopy using Acetic Acid 2.5%
Spraying esophageal mucosa during random biopsies for Barrett's esophagus
Other Name: chromoendoscopy using ethanoic acid 2.5%

Active Comparator: Standard random esophageal biopsies
Patient will have endoscopic examination of the esophagus. Esophageal mucosa will not be sprayed with Acetic Acid 2.5%. Random biopsies taken as per standard recommendations for Barrett's esophagus. Samples submitted for pathology review.
Other: Standard random esophageal biopsies
Random esophageal biopsies performed as per protocol




Primary Outcome Measures :
  1. Total number of subjects with neoplasia when using acetic acid chromoendoscopy versus standardized random biopsies. [ Time Frame: 18 months ]
    Spray of Acetic Acid into the esophageal mucosa during routine esophageal biopsies for Barrett's esophagus surveillance increases the yield of neoplasia.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 years and older
  • Previous diagnosis of Barrett's esophagus, confirmed by pathology.

Exclusion Criteria:

  • Patients diagnosed with any level of dysplasia on previous esophageal biopsies.
  • Patients who had esophageal therapy with Halo radiofrequency ablation in the past, or esophagectomy.
  • History of allergy to Acetic Acid
  • History of esophageal dysplasia or cancer
  • Esophageal ulcerations
  • Esophageal Candida
  • Esophageal Varices
  • Patients with active esophagitis
  • Patients who cannot provide a valid consent
  • Patients who are currently pregnant

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): NCT02614703


Contacts
Contact: Ivy Hernandez, RN 9563627391 Ivy.Hernandez@dhr-rgv.com
Contact: Ingrid M Chacon, MD 9562079844 incharo3@gmail.com

Locations
United States, Texas
Doctors Hospital at Renaissance/Endoscopy Department Recruiting
Edinburg, Texas, United States, 78539
Contact: Ivy Hernandez, RN    956-362-7391    Ivy.hernandez@dhr-rgv.com   
Contact: Ingrid Chacon, MD    956-207-9844    I.Chacon@dhr-rgv.com   
Principal Investigator: Ingrid Chacon, MD         
Sponsors and Collaborators
Doctors Hospital at Renaissance
Investigators
Principal Investigator: Ingrid M Chacon, MD Doctor's Hospital at Renaissance

Publications:
Responsible Party: Ingrid Chacon, MD, Gastroenterology Specialist, Doctors Hospital at Renaissance
ClinicalTrials.gov Identifier: NCT02614703     History of Changes
Other Study ID Numbers: 0000001
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual data available unless otherwise asked for safety reason.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ingrid Chacon, MD, Doctors Hospital at Renaissance:
Barrett's Esophagus
Acetic Acid Chromoendoscopy

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Retinol acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents