Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia

Study Overview
=================
Brief Summary
-----------------
Radiofrequency ablation versus endoscopic surveillance in the management of low grade dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.

Detailed Description
-----------------
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

Official Title
-----------------
Endoscopic Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia: a Randomised Controlled Trial vs Endoscopic Surveillance

Conditions
-----------------
Barrett Oesophagus, Low Grade Dysplasia

Intervention / Treatment
-----------------
* Procedure: Endoscopic radiofrequency ablation
* Other: Endoscopic surveillance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BE with certain LGD in at least one endoscopic biopsy sample BE with maximal length of 12cm (Prague classification ≤ C12) BE with minimal length of 1cm circumferentially or 3cm in case of a unique zone (Prague classification ≥ C1 or C0M3) Patients aged between 18 and 80 years Patients' consent for study enrollment No contra-indications to general anaesthesia Patients ability to take PPI oral medication Patient affiliated to a social security system No pregnancy and active contraceptions for women in age to procreate In case of previous endoscopic mucosal resection for HGD in BE: at least one year of surveillance and 2 biopsy series with LGD without HGD Exclusion Criteria: BE length > 12cm or < 1cm circumferentially (< C1) or < 3cm focally (<M3) HGD or adenocarcinoma needing a specific endoscopic or surgical treatment Active peptic oesophagitis (Savary III or IV) Presence of surgical staples on the area to be treated Radiation oesophagitis of radiotherapy whose field includes the lower oesophagus previous oesophagus cancer previous endoscopic destruction treatment such as photodynamic therapy or plasma argon coagulation previous Heller surgery oesophagus stenosis oesophagus varices oesophagus pathology associated with sclerodermia Severe coagulation disorders or thrombopenia Anaesthesia contra-indications (ASA 4) Hypersensitivity to fluorescein or any component of the fluorescein Life expectancy < 2 years Disability to take PPI oral medication or follow the protocol surveillance Schedule

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency ablation<br>Endoscopic radiofrequency ablation of BE | Procedure: Endoscopic radiofrequency ablation<br>* 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<br>|
| Active Comparator: Surveillance<br>Endoscopic surveillance and PPI treatment | Other: Endoscopic surveillance<br>* Upper gastro-intestinal endoscopy every 6 to 12 month under propofol sedation with acetic acid magnification of mucosa and multiple biopsy samples.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of low grade dysplasia 3 years after randomization |  | 3 years after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of low grade dysplasia in each group |  | 1 and 5 years after randomization | 
| Rate of complete eradication of Barrett oesophagus |  | 1, 3 and 5 years after randomization | 
| Incidence of high grade dysplasia and adenocarcinoma |  | 3, 5 years after randomization | 
| Cost - efficacy comparison of the 2 strategies |  | 5 years | 
| Rate of complications in radiofrequency ablation group |  | 5 years after randomization | 
| Detection rate of dysplasia and Barrett's oesophagus with the confocal endomicroscopy technique |  | before treatment, during treatment (Month 3, Month 6, Month 9, Month 12) and after treatment (1, 3 and 5 years after randomization) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barrett oesophagus, Low grade dysplasia, Radiofrequency ablation