Comparing EndoRotor Device and Radiofrequency Treatment for Barretts Esophagus with Dysplasia

What this Trial Is About

Barrett Esophagus is a condition where the esophageal lining changes, increasing the risk of developing precancerous tissue and adenocarcinoma. This study compares two treatment methods for Barrett Esophagus complicated by dysplasia the new EndoRotor system versus the established Radiofrequency ablation. The aim is to evaluate the effectiveness of these treatments in eradicating Barrett Esophagus and associated dysplasia. The study is randomized and controlled, conducted by the University Hospital, Angers. The EndoRotor system mechanically removes the esophageal mucosa in one session through a device that cuts and aspirates tissue, allowing for histological analysis after treatment. Radiofrequency ablation uses thermal energy to destroy the abnormal mucosa, typically requiring multiple sessions with a debridement step using acetylcysteine spray before ablation. Participants are randomly assigned to receive either EndoRotor or Radiofrequency treatment. Both methods aim to fully eradicate Barrett Esophagus tissue but differ in technique and potential costs. Participants will undergo endoscopic evaluations before and after treatment, with biopsies taken to assess the presence of Barrett Esophagus and dysplasia at 3 and 12 months post-treatment. Safety assessments include monitoring discomfort, pain, and adverse events for up to 3 months. The study also evaluates the quality of tissue samples for pathological analysis, treatment cost-effectiveness, and the number of additional treatment sessions needed. Total participation may last up to a year, with multiple follow-up visits to monitor treatment success and safety.

A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus