Clinical Trial: Healing of the Esophageal Mucosa After RFA of Barrett's Esophagus

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Healing of the Esophageal Mucosa After Radiofrequency Ablation of Barrett's Esophagus

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 Barrett's esophagus.

Detailed 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. 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 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.


Sponsor: Dallas VA Medical Center

Current Primary Outcome: Change in Mucosal Healing [ Time Frame: 1 week, 2 weeks, 4 weeks ]

% of the esophageal mucosa healed 1 week, 2 weeks, and 4 weeks after RFA


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in inflammatory cell infiltrate [ Time Frame: 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
  • Change in expression of genes associated with epithelial-mesenchymal transition, stem cells, and submucosal glands [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Dallas VA Medical Center

Dates:
Date Received: February 11, 2016
Date Started: March 2016
Date Completion: December 2018
Last Updated: February 17, 2016
Last Verified: February 2016