Clinical trial NCT02688114: 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
Overall status: COMPLETED
Phase: NA
Conditions: Barrett Esophagus
Lead sponsor: Dallas VA Medical Center
Sponsor class: FED
First posted: 2016-02-23
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in the Percent of Mucosa Healed by Neosquamous Epithelium
timeFrame: 1 week, 2 weeks, 4 weeks
Secondary outcomes:
measure: Change in expression of genes associated with epithelial-mesenchymal transition, stem cells, and submucosal glands
timeFrame: 1 week, 2 weeks, 4 weeks
measure: Change in inflammatory cell infiltrate
timeFrame: 1 week, 2 weeks, 4 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott and White Research Institute
state: Texas
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
Study officials:
affiliation: Baylor Scott and White Research Institute
name: Stuart J Spechler, MD
role: PRINCIPAL_INVESTIGATOR
References: