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

NCT ID: NCT02688114

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-18
• Study Completion Date: 2020-01-29

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.

Conditions

Barrett Esophagus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Barrett's Esophagus Treatment

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.

Group Type: EXPERIMENTAL

Baseline surveillance endoscopy

Intervention Type: PROCEDURE

All study participants will undergo endoscopy with NinePoint NvisionVLE volumetric laser endomicroscopy and biopsy of the esophageal mucosa and gastric cardia.

Radiofrequency ablation

Intervention Type: PROCEDURE

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

Follow up endoscopy 1

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

All study participants will undergo follow up endoscopy 4 weeks after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.

Interventions

Baseline surveillance endoscopy

All study participants will undergo endoscopy with NinePoint NvisionVLE volumetric laser endomicroscopy and biopsy of the esophageal mucosa and gastric cardia.

Intervention Type: PROCEDURE

Radiofrequency ablation

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

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dallas VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Stuart Spechler

Chief, Division of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stuart J Spechler, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Scott and White Research Institute

Locations

Baylor Scott and White Research Institute

Dallas, Texas, United States

Dallas VA Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

15-076

Identifier Type: -

Identifier Source: org_study_id