Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia (RF-DBG)
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|ClinicalTrials.gov Identifier: NCT01360541|
Recruitment Status : Active, not recruiting
First Posted : May 25, 2011
Last Update Posted : March 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Barrett Oesophagus Low Grade Dysplasia||Procedure: Endoscopic radiofrequency ablation Other: Endoscopic surveillance||Phase 2|
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
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Prevalence of low grade dysplasia 3 years after randomization [ Time Frame: 3 years after randomization ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360541
|Gastroenterology and Endoscopy department, Cochin Hospital|
|Paris, France, 75014|
|Principal Investigator:||Frederic PRAT, MD, PhD||Gastroenterology and Endoscopy department, Cochin Hospital|