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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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Radiofrequency ablation versus endoscopic surveillance in the management of low grade dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency ablation | Experimental | Endoscopic radiofrequency ablation of BE |
|
| Surveillance | Active Comparator | Endoscopic surveillance and PPI treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic radiofrequency ablation | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of low grade dysplasia 3 years after randomization | 3 years after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of low grade dysplasia in each group | 1 and 5 years after randomization | |
| Rate of complete eradication of Barrett oesophagus | 1, 3 and 5 years after randomization | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederic PRAT, MD, PhD | Gastroenterology and Endoscopy department, Cochin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology and Endoscopy department, Cochin Hospital | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33685969 | Result | 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. |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Endoscopic surveillance | Other | Upper gastro-intestinal endoscopy every 6 to 12 month under propofol sedation with acetic acid magnification of mucosa and multiple biopsy samples. |
|
| Incidence of high grade dysplasia and adenocarcinoma |
| 3, 5 years after randomization |
| Cost - efficacy comparison of the 2 strategies | 5 years |
| Rate of complications in radiofrequency ablation group | 5 years after randomization |
| 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) |
| D004066 |
| Digestive System Diseases |