Healing of the Esophageal Mucosa After RFA of Barrett's Esophagus
Condition: Barrett Esophagus
MeSH terms: Barrett Esophagus
Study type: Interventional

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.
    

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.
    

Intervention name(s): Baseline surveillance endoscopy; Radiofrequency ablation; Follow up endoscopy 1; Follow up endoscopy 2; Follow up endoscopy 3
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): All study participants will undergo endoscopy with NinePoint NvisionVLE volumetric laser endomicroscopy and biopsy of the esophageal mucosa and gastric cardia.; All study participants will undergo radiofrequency ablation of Barrett's esophagus; All study participants will undergo follow up endoscopy 1 week after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.; All study participants will undergo follow up endoscopy 2 weeks after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.; All study participants will undergo follow up endoscopy 4 weeks after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science