Healing of the Esophageal Mucosa After RFA of Barrett's Esophagus
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Barrett's Esophagus Treatment 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. |
Procedure: Baseline surveillance endoscopy
All study participants will undergo endoscopy with NinePoint NvisionVLE volumetric laser endomicroscopy and biopsy of the esophageal mucosa and gastric cardia.
Procedure: Radiofrequency ablation
All study participants will undergo radiofrequency ablation of Barrett's esophagus
Procedure: Follow up endoscopy 1
All study participants will undergo follow up endoscopy 1 week after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.
Procedure: Follow up endoscopy 2
All study participants will undergo follow up endoscopy 2 weeks after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.
Procedure: Follow up endoscopy 3
All study participants will undergo follow up endoscopy 4 weeks after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.
|
Outcome Measures
Primary Outcome Measures
- Change in the Percent of Mucosa Healed by Neosquamous Epithelium [1 week, 2 weeks, 4 weeks]
% of the esophageal mucosa healed by Neosquamous epithelium at 1 week, 2 weeks, and 4 weeks after RFA
Secondary Outcome Measures
- Change in expression of genes associated with epithelial-mesenchymal transition, stem cells, and submucosal glands [1 week, 2 weeks, 4 weeks]
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.
- Change in inflammatory cell infiltrate [1 week, 2 weeks, 4 weeks]
Measurement of the changes in inflammatory cell infiltration (neutrophils, eosinophils, lymphocytes) of the esophageal mucosa 1 week, 2 weeks, and 4 weeks after RFA
Eligibility Criteria
Criteria
Inclusion Criteria:
- Barrett's esophagus
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baylor Scott and White Research Institute | Dallas | Texas | United States | 75204 |
| 2 | Dallas VA Medical Center | Dallas | Texas | United States | 75216 |
Sponsors and Collaborators
- Dallas VA Medical Center
Investigators
- Principal Investigator: Stuart J Spechler, MD, Baylor Scott and White Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15-076