Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia (RF-DBG)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 2

Conditions

Low Grade Dysplasia

Barrett Oesophagus

Treatments

Procedure: Endoscopic radiofrequency ablation

Other: Endoscopic surveillance

Study type

Interventional

Funder types

Other

Identifiers

NCT01360541

P081240

Details and patient eligibility

About

Radiofrequency ablation versus endoscopic surveillance in the management of low grade dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.

Full 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

Enrollment

125 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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