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Completed

NCT Number: NCT02688114

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

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.

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Key information

Conditions

Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Scott and White Research Institute, Dallas, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baseline surveillance endoscopy

Procedure

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

Radiofrequency ablation

Procedure

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

Follow up endoscopy 1

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

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

Procedure

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

Primary outcomes

  1. Change in the Percent of Mucosa Healed by Neosquamous Epithelium

    Time frame: 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 outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Dallas VA Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 23, 2016
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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