Healing of the Esophageal Mucosa After RFA of Barrett's Esophagus
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/29/2018 |
| Start Date: | March 2016 |
| End Date: | June 2019 |
Healing of the Esophageal Mucosa After Radiofrequency Ablation 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.
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.
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.
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.
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
We found this trial at
2
sites
Dallas VA Medical Center VA North Texas Health Care System (VANTHCS) is a progressive health...
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