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
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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
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 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 |

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

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

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
France | |
Gastroenterology and Endoscopy department, Cochin Hospital | |
Paris, France, 75014 |
Principal Investigator: | Frederic PRAT, MD, PhD | Gastroenterology and Endoscopy department, Cochin Hospital |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT01360541 History of Changes |
Other Study ID Numbers: |
P081240 |
First Posted: | May 25, 2011 Key Record Dates |
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 |