Clinical trial NCT01360541: Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia
Official title: Endoscopic Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia: a Randomised Controlled Trial vs Endoscopic Surveillance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Barrett Oesophagus
Low Grade Dysplasia
Keywords: Barrett oesophagus
Low grade dysplasia
Radiofrequency ablation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-05-25
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Prevalence of low grade dysplasia 3 years after randomization
timeFrame: 3 years after randomization
Secondary outcomes:
measure: Prevalence of low grade dysplasia in each group
timeFrame: 1 and 5 years after randomization
measure: Rate of complete eradication of Barrett oesophagus
timeFrame: 1, 3 and 5 years after randomization
measure: Incidence of high grade dysplasia and adenocarcinoma
timeFrame: 3, 5 years after randomization
measure: Cost - efficacy comparison of the 2 strategies
timeFrame: 5 years
measure: Rate of complications in radiofrequency ablation group
timeFrame: 5 years after randomization
measure: Detection rate of dysplasia and Barrett's oesophagus with the confocal endomicroscopy technique
timeFrame: before treatment, during treatment (Month 3, Month 6, Month 9, Month 12) and after treatment (1, 3 and 5 years after randomization)
Other outcomes:
Locations:
city: Paris
country: France
facility: Gastroenterology and Endoscopy department, Cochin Hospital
Study officials:
affiliation: Gastroenterology and Endoscopy department, Cochin Hospital
name: Frederic PRAT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barret M, Pioche M, Terris B, Ponchon T, Cholet F, Zerbib F, Chabrun E, Le Rhun M, Coron E, Giovannini M, Caillol F, Laugier R, Jacques J, Legros R, Boustiere C, Rahmi G, Metivier-Cesbron E, Vanbiervliet G, Bauret P, Escourrou J, Branche J, Jilet L, Abdoul H, Kaddour N, Leblanc S, Bensoussan M, Prat F, Chaussade S. Endoscopic radiofrequency ablation or surveillance in patients with Barrett's oesophagus with confirmed low-grade dysplasia: a multicentre randomised trial. Gut. 2021 Jun;70(6):1014-1022. doi: 10.1136/gutjnl-2020-322082. Epub 2021 Mar 8.