Study ID: F/N-R20-3895L
Effect of vitamin A (retinol) on esophageal neosquamous epithelia induced by radiofrequency ablation
BE is a condition that arises from chronic heartburn or gastroesophageal reflux disease and can lead to cancer of the esophagus. RFA is a nonsurgical procedure that uses a spectrum of energy to produce a highly localized heat-like effect on the tissue in order to destroy the dysplastic Barrett’s region.
Researchers seek to determine if vitamin A can modify and improve the esophageal lining after RFA. It is theorized that modification of the lining may result in the healed esophageal lining being less affected by refluxed acid. A secondary focus is on the effects of vitamin A supplementation on the duodenum.
Eligible patients for this study are randomized into one of two study arms. One group receives treatment with orally administered vitamin A. The other group receives a placebo.
This prospective, randomized study is to determine if orally administered retinoic acid (10,000 – 25,000 IU) can induce modification of the esophageal lining at the level of the epithelial tight junctional seals in patients who have undergone RFA of their Barrett’s tissue. The modification of the new esophageal lining may be less leaky to refluxed acid.
The study focuses on the neosquamous epithelium that refoliates the esophagus lining after RFA, with a secondary focus on the effects of retinoic acid supplementation on the duodenal tight junctional seals.
- Must have been diagnosed with BE
- Must have already undergone RFA at least four weeks before trial enrollment
- Must not be pregnant