Barrett EsophagusNCT02688114
Healing of the Esophageal Mucosa After RFA of Barrett's Esophagus
A study testing Baseline surveillance endoscopy, Radiofrequency ablation and Follow up endoscopy 1 in people with Barrett Esophagus, run by Dallas VA Medical Center at 2 sites in United States.
Trial summary
Radiofrequency ablation (RFA) is a mainstay of treatment for patients who have Barrett's esophagus (BE) with dysplasia. For unclear reasons, Barrett's esophagus recurs after successful RFA treatment in approximately 1/3 of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Baseline surveillance endoscopy, Radiofrequency ablation and Follow up endoscopy 1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Oct 2017to 29 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Barrett's esophagus
Who cannot join
- inability to provide informed consent
- esophageal varices
- treatment with warfarin
- coagulopathy that precludes safe biopsy of the esophagus (including platelet count <100,000/mm3, INR (international normalized ratio) >1.5)
- allergy to fluorescein sodium
- comorbidity that precludes safe participation in the study
- pregnancy or breastfeeding status
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor Scott and White Research Institute
Dallas, Texas, 75204
Dallas VA Medical Center
Dallas, Texas, 75216
About this study
Official title: Healing of the Esophageal Mucosa After Radiofrequency Ablation of Barrett's Esophagus
Radiofrequency ablation (RFA) is a mainstay of treatment for patients who have Barrett's esophagus (BE) with dysplasia. For unclear reasons, Barrett's esophagus recurs after successful RFA treatment in approximately 1/3 of patients. The aim of this study is to characterize the healing process of the esophageal mucosa, histologically and at the molecular level, after RFA for non-dysplastic and dysplastic Barrett's esophagus.
Read the detailed description
Radiofrequency ablation (RFA) is a mainstay of treatment for patients who have Barrett's esophagus (BE) with dysplasia. For unclear reasons, Barrett's esophagus recurs after successful RFA treatment in approximately 1/3 of patients. Little is known of how the esophagus heals after RFA treatment, and a better understanding of this healing process might provide insights into how to prevent Barrett's metaplasia from recurring after successful ablation.
The aim of this study is to characterize the healing process of the esophageal mucosa, histologically and at the molecular level, after RFA for non-dysplastic and dysplastic Barrett's esophagus. Patients with Barrett's esophagus will undergo surveillance endoscopy with biopsy. This will be followed by RFA treatment of the BE and follow up endoscopy will be performed 1, 2, and 4 weeks after RFA. Healing at each time point will be assessed endoscopically, and molecular markers related to healing will be studied. Stem cell expression markers, immune cells and markers of epithelial-mesenchymal transition will be compared with baseline expression for each patient. Protocol has been modified to provide a collaborative effort between the Dallas VAMC and Baylor Scott \& White Medical Center in Dallas, TX. Veteran participants electing to participate will receive initial screening and endoscopy at the Dallas VAMC and will continue with RFA and follow-up endoscopies at Baylor. An identical protocol has been approved at Baylor Scott \& White Medical center. Patients who are screened and enrolled at Baylor will receive all treatments at that location.
- Conditions
- Barrett Esophagus
- Being tested
- Baseline surveillance endoscopy, Radiofrequency ablation, Follow up endoscopy 1, Follow up endoscopy 2, Follow up endoscopy 3
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline surveillance endoscopyProcedure or surgery
All study participants will undergo endoscopy with NinePoint NvisionVLE volumetric laser endomicroscopy and biopsy of the esophageal mucosa and gastric cardia.
Radiofrequency ablationProcedure or surgery
All study participants will undergo radiofrequency ablation of Barrett's esophagus
Follow up endoscopy 1Procedure or surgery
All study participants will undergo follow up endoscopy 1 week after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.
Follow up endoscopy 2Procedure or surgery
All study participants will undergo follow up endoscopy 2 weeks after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.
Follow up endoscopy 3Procedure or surgery
All study participants will undergo follow up endoscopy 4 weeks after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.
| Study group | Role | What they receive |
|---|---|---|
| Barrett's Esophagus Treatment | Experimental | All participants are in the treatment arm. Patients with Barrett's esophagus will undergo baseline surveillance endoscopy, be treated with radiofrequency ablation, and undergo follow up endoscopy 1, follow up endoscopy 2, and follow up endoscopy 3. Receives: Procedure: Baseline surveillance endoscopy; Procedure: Radiofrequency ablation; Procedure: Follow up endoscopy 1; Procedure: Follow up endoscopy 2; Procedure: Follow up endoscopy 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Percent of Mucosa Healed by Neosquamous Epithelium
% of the esophageal mucosa healed by Neosquamous epithelium at 1 week, 2 weeks, and 4 weeks after RFA
Measured: 1 week, 2 weeks, 4 weeks
Secondary outcomes (2)
Change in expression of genes associated with epithelial-mesenchymal transition, stem cells, and submucosal glands
Measurement of gene expression in the esophageal mucosa 1 week, 2 weeks, 4 weeks after RFA. Genes related to the process of epithelial-mesenchymal transition, stem cells and submucosal glands will be studied.
Measured: 1 week, 2 weeks, 4 weeks
Change in inflammatory cell infiltrate
Measurement of the changes in inflammatory cell infiltration (neutrophils, eosinophils, lymphocytes) of the esophageal mucosa 1 week, 2 weeks, and 4 weeks after RFA
Measured: 1 week, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start18 Oct 2017
- Primary completion29 Jan 2020
- Study completion29 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dallas VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Stuart Spechler, Dallas VA Medical Center
- Investigators
- Stuart J Spechler, MD, Principal investigator, Baylor Scott & White The Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688114
- Sponsor's protocol ID
- 15-076
- Status last verified
- Sep 2023
- First submitted
- 11 Feb 2016
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing of the Esophageal Mucosa After Radiofrequency Ablation of Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT02688114
- Acronym / sponsor ID
- 15-076
- Conditions
- Barrett Esophagus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Dallas VA Medical CenterUS federal agency
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 29 Jan 2020 (actual)
- Study completion
- 29 Jan 2020 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radiofrequency ablation (RFA) is a mainstay of treatment for patients who have Barrett's esophagus (BE) with dysplasia. For unclear reasons, Barrett's esophagus recurs after successful RFA treatment in approximately 1/3 of patients. The aim of this study is to characterize the healing process of the esophageal mucosa, histologically and at the molecular level, after RFA for non-dysplastic and dysplastic Barrett's esophagus.
Detailed description
Radiofrequency ablation (RFA) is a mainstay of treatment for patients who have Barrett's esophagus (BE) with dysplasia. For unclear reasons, Barrett's esophagus recurs after successful RFA treatment in approximately 1/3 of patients. Little is known of how the esophagus heals after RFA treatment, and a better understanding of this healing process might provide insights into how to prevent Barrett's metaplasia from recurring after successful ablation.
The aim of this study is to characterize the healing process of the esophageal mucosa, histologically and at the molecular level, after RFA for non-dysplastic and dysplastic Barrett's esophagus. Patients with Barrett's esophagus will undergo surveillance endoscopy with biopsy. This will be followed by RFA treatment of the BE and follow up endoscopy will be performed 1, 2, and 4 weeks after RFA. Healing at each time point will be assessed endoscopically, and molecular markers related to healing will be studied. Stem cell expression markers, immune cells and markers of epithelial-mesenchymal transition will be compared with baseline expression for each patient. Protocol has been modified to provide a collaborative effort between the Dallas VAMC and Baylor Scott \& White Medical Center in Dallas, TX. Veteran participants electing to participate will receive initial screening and endoscopy at the Dallas VAMC and will continue with RFA and follow-up endoscopies at Baylor. An identical protocol has been approved at Baylor Scott \& White Medical center. Patients who are screened and enrolled at Baylor will receive all treatments at that location.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Barrett's Esophagus Treatment | Experimental | Procedure: Baseline surveillance endoscopy, Procedure: Radiofrequency ablation, Procedure: Follow up endoscopy 1, Procedure: Follow up endoscopy 2, Procedure: Follow up endoscopy 3All participants are in the treatment arm. Patients with Barrett's esophagus will undergo baseline surveillance endoscopy, be treated with radiofrequency ablation, and undergo follow up endoscopy 1, follow up endoscopy 2, and follow up endoscopy 3. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Barrett's esophagus
Key exclusion criteria (7 listed)
- inability to provide informed consent
- esophageal varices
- treatment with warfarin
- coagulopathy that precludes safe biopsy of the esophagus (including platelet count <100,000/mm3, INR (international normalized ratio) >1.5)
- allergy to fluorescein sodium
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 |
|---|---|---|
| Baseline surveillance endoscopyAll study participants will undergo endoscopy with NinePoint NvisionVLE volumetric laser endomicroscopy and biopsy of the esophageal mucosa and gastric cardia. | Procedure or surgery | Barrett's Esophagus Treatment |
| Radiofrequency ablationAll study participants will undergo radiofrequency ablation of Barrett's esophagus | Procedure or surgery | Barrett's Esophagus Treatment |
| Follow up endoscopy 1All study participants will undergo follow up endoscopy 1 week after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies. | Procedure or surgery | Barrett's Esophagus Treatment |
| Follow up endoscopy 2All study participants will undergo follow up endoscopy 2 weeks after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies. | Procedure or surgery | Barrett's Esophagus Treatment |
| Follow up endoscopy 3All study participants will undergo follow up endoscopy 4 weeks after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies. | Procedure or surgery | Barrett's Esophagus Treatment |
Primary outcome
Change in the Percent of Mucosa Healed by Neosquamous Epithelium
Time frame: 1 week, 2 weeks, 4 weeks
% of the esophageal mucosa healed by Neosquamous epithelium at 1 week, 2 weeks, and 4 weeks after RFA
2 secondary outcomes
Change in expression of genes associated with epithelial-mesenchymal transition, stem cells, and submucosal glands
Time frame: 1 week, 2 weeks, 4 weeks
Change in inflammatory cell infiltrate
Time frame: 1 week, 2 weeks, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Barrett Esophagus
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"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
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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.
Stuart J Spechler, MD principal investigator
Baylor Scott & White The Heart Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline surveillance endoscopy, Radiofrequency ablation and Follow up endoscopy 1 in people with Barrett Esophagus, run by Dallas VA Medical Center at 2 sites 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the Percent of Mucosa Healed by Neosquamous Epithelium (time frame: 1 week, 2 weeks, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2023.