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

Primary Purpose

Barrett Esophagus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baseline surveillance endoscopy
Radiofrequency ablation
Follow up endoscopy 1
Follow up endoscopy 2
Follow up endoscopy 3
Sponsored by
Dallas VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Barrett Esophagus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baylor Scott and White Research Institute
  • Dallas VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Barrett's Esophagus Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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

Full Information

First Posted
February 11, 2016
Last Updated
September 7, 2023
Sponsor
Dallas VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02688114
Brief Title
Healing of the Esophageal Mucosa After RFA of Barrett's Esophagus
Official Title
Healing of the Esophageal Mucosa After Radiofrequency Ablation of Barrett's Esophagus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2017 (Actual)
Primary Completion Date
January 29, 2020 (Actual)
Study Completion Date
January 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dallas VA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Barrett's Esophagus Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Baseline surveillance endoscopy
Intervention Description
All study participants will undergo endoscopy with NinePoint NvisionVLE volumetric laser endomicroscopy and biopsy of the esophageal mucosa and gastric cardia.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation
Intervention Description
All study participants will undergo radiofrequency ablation of Barrett's esophagus
Intervention Type
Procedure
Intervention Name(s)
Follow up endoscopy 1
Intervention Description
All study participants will undergo follow up endoscopy 1 week after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.
Intervention Type
Procedure
Intervention Name(s)
Follow up endoscopy 2
Intervention Description
All study participants will undergo follow up endoscopy 2 weeks after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.
Intervention Type
Procedure
Intervention Name(s)
Follow up endoscopy 3
Intervention Description
All study participants will undergo follow up endoscopy 4 weeks after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.
Primary Outcome Measure Information:
Title
Change in the Percent of Mucosa Healed by Neosquamous Epithelium
Description
% of the esophageal mucosa healed by Neosquamous epithelium at 1 week, 2 weeks, and 4 weeks after RFA
Time Frame
1 week, 2 weeks, 4 weeks
Secondary Outcome Measure Information:
Title
Change in expression of genes associated with epithelial-mesenchymal transition, stem cells, and submucosal glands
Description
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.
Time Frame
1 week, 2 weeks, 4 weeks
Title
Change in inflammatory cell infiltrate
Description
Measurement of the changes in inflammatory cell infiltration (neutrophils, eosinophils, lymphocytes) of the esophageal mucosa 1 week, 2 weeks, and 4 weeks after RFA
Time Frame
1 week, 2 weeks, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart J Spechler, MD
Organizational Affiliation
Baylor Scott and White Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor Scott and White Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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