Barrett's Esophagus
Conditions
Keywords
Barrett's Esophagus, Acetic Acid Chromoendoscopy
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.
Interventions
DRUGChromoendoscopy using Acetic Acid 2.5%
Spraying esophageal mucosa during random biopsies for Barrett's esophagus
OTHERStandard random esophageal biopsies
Random esophageal biopsies performed as per protocol
Sponsors
DHR Health Institute for Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Subjects With Neoplasia When Using Acetic Acid Chromoendoscopy Versus Standardized Random Biopsies. | 142 seconds | Spray of Acetic Acid into the esophageal mucosa during routine esophageal biopsies for Barrett's esophagus surveillance increases the yield of neoplasia. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from our Barrett's esophageal Surveillance Program. The study took place in a South Texas Gastroenterology office. The first patient was enrolled 4-11-17. Study enrollment was stopped 7/30/18.
Pre-assignment details
Patients were assigned an arm immediately after enrollment. There were no events within the enrollment and the actual procedure. The only reason patient could have been excluded was a no-show to the procedure appointment.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Chromoendoscopy using Acetic Acid 2.5%: Spraying esophageal mucosa during random biopsies for Barrett's esophagus | 31 |
| 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.
Standard random esophageal biopsies: Random esophageal biopsies performed one biopsy per quadrant, every 2cm of Barrett's mucosa ( also known as the Bethesta Protocol) | 29 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 7 | 1 |
Baseline characteristics
| Characteristic | Chromoendoscopy Using Acetic Acid 2.5% | Standard Random Esophageal Biopsies | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 17 Participants | 34 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 12 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 25 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Number of participants with Long Segment Barrett's | 10 participants | 3 participants | 13 participants |
| Region of Enrollment United States | 31 participants | 29 participants | 60 participants |
| Sex: Female, Male Female | 9 Participants | 14 Participants | 23 Participants |
| Sex: Female, Male Male | 22 Participants | 15 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 29 |
| other Total, other adverse events | 0 / 31 | 0 / 29 |
| serious Total, serious adverse events | 0 / 31 | 0 / 29 |
Outcome results
Primary
Total Number of Subjects With Neoplasia When Using Acetic Acid Chromoendoscopy Versus Standardized Random Biopsies.
Spray of Acetic Acid into the esophageal mucosa during routine esophageal biopsies for Barrett's esophagus surveillance increases the yield of neoplasia.
Time frame: 142 seconds
Population: Thirty-one (31) patients entered the preliminary data analysis. Of these 31 patients, twenty (20) were classified as SSBE, and eleven (11) patients as Long Segment BE (LSBE). These 31 patients were confirmed to have Barrett's esophagus via biopsy and were randomized (Acetic Acid n=20, Control n=11)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chromoendoscopy Using Acetic Acid 2.5% | Total Number of Subjects With Neoplasia When Using Acetic Acid Chromoendoscopy Versus Standardized Random Biopsies. | 1 participants |
| Standard Random Esophageal Biopsies | Total Number of Subjects With Neoplasia When Using Acetic Acid Chromoendoscopy Versus Standardized Random Biopsies. | 0 participants |