Overview

This trial is active, not recruiting.

Conditions barrett oesophagus, low grade dysplasia
Treatments endoscopic radiofrequency ablation, endoscopic surveillance
Phase phase 2
Sponsor Assistance Publique - Hôpitaux de Paris
Start date December 2010
End date June 2018
Trial size 125 participants
Trial identifier NCT01360541, P081240

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Endoscopic radiofrequency ablation of BE
endoscopic radiofrequency ablation
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
(Active Comparator)
Endoscopic surveillance and PPI treatment
endoscopic surveillance
Upper gastro-intestinal endoscopy every 6 to 12 month under propofol sedation with acetic acid magnification of mucosa and multiple biopsy samples.

Primary Outcomes

Measure
Prevalence of low grade dysplasia 3 years after randomization
time frame: 3 years after randomization

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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 (

Additional Information

Official title Endoscopic Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia: a Randomised Controlled Trial vs Endoscopic Surveillance
Principal investigator Frederic PRAT, MD, PhD
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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.