Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia

Low Grade Dysplasia Clinical Trial

— RF-DBG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360541
• Other study ID #: P081240
• Status: Completed
• Phase: Phase 2
• Start date: December 22, 2010
• Est. completion date: December 14, 2018

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 14, 2018
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett Oesophagus
• Hyperplasia
• Low Grade Dysplasia

Intervention

Procedure:
• 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

Other:
• Endoscopic surveillance
Upper gastro-intestinal endoscopy every 6 to 12 month under propofol sedation with acetic acid magnification of mucosa and multiple biopsy samples.

Locations

Country	Name	City	State
France	Gastroenterology and Endoscopy department, Cochin Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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, Abdou — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of low grade dysplasia 3 years after randomization		3 years after randomization
Secondary	Prevalence of low grade dysplasia in each group		1 and 5 years after randomization
Secondary	Rate of complete eradication of Barrett oesophagus		1, 3 and 5 years after randomization
Secondary	Incidence of high grade dysplasia and adenocarcinoma		3, 5 years after randomization
Secondary	Cost - efficacy comparison of the 2 strategies		5 years
Secondary	Rate of complications in radiofrequency ablation group		5 years after randomization
Secondary	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)