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

Barrett Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688114
• Other study ID #: 15-076
• Status: Completed
• Phase: N/A
• Start date: October 18, 2017
• Est. completion date: January 29, 2020

Study information

• Verified date: September 2023
• Source: Dallas VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 29, 2020
• Est. primary completion date: January 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus

Intervention

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.
• Radiofrequency ablation
All study participants will undergo radiofrequency ablation of Barrett's esophagus
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Baylor Scott and White Research Institute	Dallas	Texas
United States	Dallas VA Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Dallas VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 week, 2 weeks, 4 weeks
Secondary	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.	1 week, 2 weeks, 4 weeks
Secondary	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	1 week, 2 weeks, 4 weeks