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"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02614703
Recruitment Status : Terminated (Sample was under-powered)
First Posted : November 25, 2015
Results First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ingrid Chacon, MD, Doctors Hospital at Renaissance

Tracking Information
First Submitted Date  ICMJE July 30, 2015
First Posted Date  ICMJE November 25, 2015
Results First Submitted Date  ICMJE March 20, 2019
Results First Posted Date  ICMJE August 26, 2019
Last Update Posted Date August 26, 2019
Actual Study Start Date  ICMJE March 10, 2017
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
Total Number of Subjects With Neoplasia When Using Acetic Acid Chromoendoscopy Versus Standardized Random Biopsies. [ Time Frame: 142 seconds ]
Spray of Acetic Acid into the esophageal mucosa during routine esophageal biopsies for Barrett's esophagus surveillance increases the yield of neoplasia.
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2015)
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.
Change History Complete list of historical versions of study NCT02614703 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE "Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance
Official Title  ICMJE "Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance is Superior to the Standardized Random Biopsy Protocol in Detecting Neoplasia: A Prospective Randomized Study"
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Barrett's Esophagus
Intervention  ICMJE
  • 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%
  • Other: Standard random esophageal biopsies
    Random esophageal biopsies performed as per protocol
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Chromoendoscopy using Acetic 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.
    Intervention: Other: Standard random esophageal biopsies
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 22, 2019)
60
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2015)
185
Actual Study Completion Date  ICMJE July 30, 2018
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02614703
Other Study ID Numbers  ICMJE 0000001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to make individual data available unless otherwise asked for safety reason.
Responsible Party Ingrid Chacon, MD, Doctors Hospital at Renaissance
Study Sponsor  ICMJE Doctors Hospital at Renaissance
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ingrid M Chacon, MD Doctor's Hospital at Renaissance
PRS Account Doctors Hospital at Renaissance
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP