Clinical trial NCT02614703: "Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance
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"
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Barrett's Esophagus
Keywords: Barrett's Esophagus
Acetic Acid Chromoendoscopy
Lead sponsor: DHR Health Institute for Research and Development
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Total Number of Subjects With Neoplasia When Using Acetic Acid Chromoendoscopy Versus Standardized Random Biopsies.
timeFrame: 142 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburg
country: United States
facility: Doctors Hospital at Renaissance/Endoscopy Department
state: Texas
Study officials:
affiliation: Doctor's Hospital at Renaissance
name: Ingrid M Chacon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Longcroft-Wheaton G, Duku M, Mead R, Poller D, Bhandari P. Acetic acid spray is an effective tool for the endoscopic detection of neoplasia in patients with Barrett's esophagus. Clin Gastroenterol Hepatol. 2010 Oct;8(10):843-7. doi: 10.1016/j.cgh.2010.06.016. Epub 2010 Jun 30.
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.