Low Grade Dysplasia Clinical Trial
Official title:
Endoscopic Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia: a Randomised Controlled Trial vs Endoscopic Surveillance
Radiofrequency ablation versus endoscopic surveillance in the management of low grade dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.
Background: The occurrence of low grade dysplasia (LGD) in Barrett oesophagus (BE) is known as a pre-cancerous state. Current recommendation in case of LGD is a close endoscopic surveillance every 6 to 12 month and continuous Proton pomp inhibitor (PPI) treatment. Endoscopic radiofrequency ablation (RFA) has been demonstrated as an efficient treatment to eradicate high grade dysplasia (HGD) and most of LGD and BE. Main aim of this study: To demonstrate that the prevalence of patients with LGD 3 years after a RFA treatment is lower than in a surveillance group. Patients & Methods: French multicentric randomized controlled trial for patients with BE with confirmed LGD: RFA vs endoscopic surveillance. 120 patients are planned to be included for at least 40 patients randomized in each group. Primary endpoint: Prevalence of LGD in each group 3 years after randomization Secondary endpoints: - Prevalence of LGD in each group 1 and 5 years after randomization - Rate of complete eradication of BE at 1, 3 and 5 years after randomization - Incidence of HGD and adenocarcinoma at 3, 5 years after randomization - Rate of complications in RFA group after randomization - Cost - efficacy comparison of the 2 strategies ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00526786 -
Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus
|
Phase 4 |