Healing of the Esophageal Mucosa After RFA of Barrett's Esophagus

Not Applicable

Completed

• Conditions: Barrett Esophagus
• Interventions: Procedure: Baseline surveillance endoscopy; Procedure: Radiofrequency ablation; Procedure: Follow up endoscopy 1; Procedure: Follow up endoscopy 2; Procedure: Follow up endoscopy 3

• Registration Number: NCT02688114
• Lead Sponsor: Dallas VA Medical Center

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.

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 Timeline

• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-23
• Study Start: 2017-10-18
• Primary Completion: 2020-01-29
• Study Completion: 2020-01-29
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Barrett's Esophagus Treatment	Follow up endoscopy 1	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.
Barrett's Esophagus Treatment	Follow up endoscopy 2	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.
Barrett's Esophagus Treatment	Follow up endoscopy 3	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.
Barrett's Esophagus Treatment	Baseline surveillance endoscopy	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.
Barrett's Esophagus Treatment	Radiofrequency ablation	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Dallas VA Medical Center; 🇺🇸 Dallas, Texas, United States

Baylor Scott and White Research Institute; 🇺🇸 Dallas, Texas, United States