CompletedPhase 2

Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia

France125 participantsStarted 2010-12-22

Plain-language summary

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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prevalence of low grade dysplasia 3 years after randomization

Timeframe: 3 years after randomization

Trial details

NCT IDNCT01360541

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-14

View on ClinicalTrials.gov More Barrett Oesophagus trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.