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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Barrett Oesophagus; Low Grade Dysplasia	Procedure: Endoscopic radiofrequency ablation; Other: Endoscopic surveillance	Phase 2

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	125 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Endoscopic Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia: a Randomised Controlled Trial vs Endoscopic Surveillance
Actual Study Start Date :	December 22, 2010
Estimated Primary Completion Date :	June 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Radiofrequency ablation; Endoscopic radiofrequency ablation of BE	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
Active Comparator: Surveillance; Endoscopic surveillance and PPI treatment	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.

Outcome Measures

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Primary Outcome Measures :

1. Prevalence of low grade dysplasia 3 years after randomization [ Time Frame: 3 years after randomization ]

Secondary Outcome Measures :

1. Prevalence of low grade dysplasia in each group [ Time Frame: 1 and 5 years after randomization ]
2. Rate of complete eradication of Barrett oesophagus [ Time Frame: 1, 3 and 5 years after randomization ]
3. Incidence of high grade dysplasia and adenocarcinoma [ Time Frame: 3, 5 years after randomization ]
4. Cost - efficacy comparison of the 2 strategies [ Time Frame: 5 years ]
5. Rate of complications in radiofrequency ablation group [ Time Frame: 5 years after randomization ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)
• 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)
• Life expectancy < 2 years
• Disability to take PPI oral medication or follow the protocol surveillance schedule

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
Gastroenterology and Endoscopy department, Cochin Hospital
Paris, France, 75014

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:	Frederic PRAT, MD, PhD	Gastroenterology and Endoscopy department, Cochin Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT01360541 History of Changes
Other Study ID Numbers:	P081240
First Posted:	May 25, 2011
Last Update Posted:	March 19, 2018
Last Verified:	March 2018

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Barrett oesophagus; Low grade dysplasia; Radiofrequency ablation

Additional relevant MeSH terms:

Hyperplasia; Barrett Esophagus; Pathologic Processes; Digestive System Abnormalities	Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases