Barrett's EsophagusPhase 2/3NCT02614703
"Acetic Acid Chromoendoscopy in Barrett's Esophagus Surveillance
A Phase 2/3 study testing Chromoendoscopy using Acetic Acid 2.5% and Standard random esophageal biopsies in people with Barrett's Esophagus, run by DHR Health Institute for Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Barrett's Esophagus
- What is being tested?
- Chromoendoscopy using Acetic Acid 2.5% and Standard random esophageal biopsies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2017to 30 Jul 2018
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years and older
- Previous diagnosis of Barrett's esophagus, confirmed by pathology.
Who cannot join
- 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
Show all 10Show fewer
- Esophageal Varices
- Patients with active esophagitis
- Patients who cannot provide a valid consent
- Patients who are currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Doctors Hospital at Renaissance/Endoscopy Department
Edinburg, Texas, 78539
About this study
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"
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.
Read the 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.
- Conditions
- Barrett's Esophagus
- Being tested
- Chromoendoscopy using Acetic Acid 2.5%, Standard random esophageal biopsies
- Keywords
- Barrett's Esophagus, Acetic Acid Chromoendoscopy
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chromoendoscopy using Acetic Acid 2.5%Drug
Also called chromoendoscopy using ethanoic acid 2.5%
Spraying esophageal mucosa during random biopsies for Barrett's esophagus
Standard random esophageal biopsiesOther
Random esophageal biopsies performed as per protocol
| Study group | Role | What they receive |
|---|---|---|
| Chromoendoscopy using Acetic Acid 2.5% | Experimental | 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. Receives: Drug: Chromoendoscopy using Acetic Acid 2.5% |
| Standard random esophageal biopsies | Active comparator | 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. Receives: Other: Standard random esophageal biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 142 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study start10 Mar 2017
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Why it stopped: Sample was under-powered
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- DHR Health Institute for Research and Development
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingrid Chacon, DHR Health Institute for Research and Development
- Investigators
- Ingrid M Chacon, MD, Principal investigator, Doctor's Hospital at Renaissance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614703
- Sponsor's protocol ID
- 0000001
- Status last verified
- Aug 2021
- First submitted
- 30 Jul 2015
- Last updated
- 27 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual data available unless otherwise asked for safety reason.
Publications
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.
PubMed 20601133Tholoor 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.
PubMed 24713305
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT02614703
- Acronym / sponsor ID
- 0000001
- Conditions
- Barrett's Esophagus
- Keywords
- Barrett's Esophagus, Acetic Acid Chromoendoscopy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sample was under-powered
- Enrolment
- 60 participants (actual)
- Lead sponsor
- DHR Health Institute for Research and DevelopmentUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Posted 26 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chromoendoscopy using Acetic Acid 2.5% | Experimental | Drug: 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. |
| Standard random esophageal biopsies | Active comparator | Other: Standard random esophageal biopsiesPatient 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years and older
- Previous diagnosis of Barrett's esophagus, confirmed by pathology.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chromoendoscopy using Acetic Acid 2.5%Also: chromoendoscopy using ethanoic acid 2.5%Spraying esophageal mucosa during random biopsies for Barrett's esophagus | Drug | Chromoendoscopy using Acetic Acid 2.5% |
| Standard random esophageal biopsiesRandom esophageal biopsies performed as per protocol | Other | Standard random esophageal biopsies |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20601133Longcroft-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.
- Background: PubMed 24713305Tholoor 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.
- Individual participant dataSharing planned: No. There is no plan to make individual data available unless otherwise asked for safety reason.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid M Chacon, MD principal investigator
Doctor's Hospital at Renaissance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Chromoendoscopy using Acetic Acid 2.5% and Standard random esophageal biopsies in people with Barrett's Esophagus, run by DHR Health Institute for Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Subjects With Neoplasia When Using Acetic Acid Chromoendoscopy Versus Standardized Random Biopsies. (time frame: 142 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02614703, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.