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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
125
HALO device Use of HALO 360° device for the fist procedure and possible use of HALo 90° device for further treatment sessions Treatment zone of 12cm high maximum. Energy delivered 10 J/cm², power 300W
Upper gastro-intestinal endoscopy every 6 to 12 month under propofol sedation with acetic acid magnification of mucosa and multiple biopsy samples.
Gastroenterology and Endoscopy department, Cochin Hospital
Paris, France
Prevalence of low grade dysplasia 3 years after randomization
Time frame: 3 years after randomization
Prevalence of low grade dysplasia in each group
Time frame: 1 and 5 years after randomization
Rate of complete eradication of Barrett oesophagus
Time frame: 1, 3 and 5 years after randomization
Incidence of high grade dysplasia and adenocarcinoma
Time frame: 3, 5 years after randomization
Cost - efficacy comparison of the 2 strategies
Time frame: 5 years
Rate of complications in radiofrequency ablation group
Time frame: 5 years after randomization
Detection rate of dysplasia and Barrett's oesophagus with the confocal endomicroscopy technique
Time frame: before treatment, during treatment (Month 3, Month 6, Month 9, Month 12) and after treatment (1, 3 and 5 years after randomization)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.