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Original research
Endoscopic radiofrequency ablation or surveillance in patients with Barrett’s oesophagus with confirmed low-grade dysplasia: a multicentre randomised trial
  1. Maximilien Barret1,
  2. Mathieu Pioche2,
  3. Benoit Terris3,
  4. Thierry Ponchon4,
  5. Franck Cholet5,
  6. Frank Zerbib6,
  7. Edouard Chabrun6,
  8. Marc Le Rhun7,
  9. Emmanuel Coron7,
  10. Marc Giovannini8,
  11. Fabrice Caillol8,
  12. René Laugier9,
  13. Jeremie Jacques10,
  14. Romain Legros10,
  15. Christian Boustiere11,
  16. Gabriel Rahmi12,
  17. Elodie Metivier-Cesbron13,
  18. Geoffroy Vanbiervliet14,
  19. Paul Bauret15,
  20. Jean Escourrou16,
  21. Julien Branche17,
  22. Lea Jilet18,
  23. Hendy Abdoul18,
  24. Nadira Kaddour18,
  25. Sarah Leblanc1,
  26. Michael Bensoussan19,
  27. Frederic Prat1,
  28. Stanislas Chaussade1
  1. 1 Gastroenterology and Digestive Oncology, Hopital Cochin, Paris, Île-de-France, France
  2. 2 Gastroenterology and Endoscopy, Groupement Hospitalier Edouard Herriot, Lyon, Rhône-Alpes, France
  3. 3 Pathology, Hopital Cochin, Paris, Île-de-France, France
  4. 4 Gastroenterology, Groupement Hospitalier Edouard Herriot, Lyon, Rhône-Alpes, France
  5. 5 Digestive Endoscopy, CHRU de Brest, Brest, Bretagne, France
  6. 6 Gastroenterology, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, Aquitaine, France
  7. 7 Gastroenterology, Centre Hospitalier Universitaire de Nantes, Nantes, Pays de la Loire, France
  8. 8 Gastroenterology, Institut Paoli-Calmettes, Marseille, Provence-Alpes-Côte d'Azur, France
  9. 9 Gastroenterology, Hospital Timone, Marseille, Provence-Alpes-Côte d'Azur, France
  10. 10 Gastroenterology, Centre Hospitalier Universitaire de Limoges, Limoges, Limousin, France
  11. 11 Gastroenterology, Hopital Saint Joseph, Marseille, Provence-Alpes-Côte d'Azu, France
  12. 12 Gastroenterology and Digestive Endoscopy, Hopital Europeen Georges Pompidou, Paris, France
  13. 13 Digestive Endoscopy Unit, Centre Hospitalier Universitaire d'Angers, Angers, Pays de la Loire, France
  14. 14 Gastroenterology, Centre Hospitalier Universitaire de Nice, Nice, Provence-Alpes-Côte d'Azur, France
  15. 15 Gastroenterology, Centre Hospitalier Universitaire de Montpellier, Montpellier, Languedoc-Roussillon, France
  16. 16 Gastroenterology, Centre Hospitalier Universitaire de Toulouse, Toulouse, Midi-Pyrénées, France
  17. 17 Gastroenterology, Centre Hospitalier Universitaire de Lille, Lille, Hauts-de-France, France
  18. 18 Clinical Research Unit, Hospital Cochin, Paris, Île-de-France, France
  19. 19 Gastroenterology, Centre intégré de santé et de services sociaux de la Montérégie-Centre du Québec territoire Champlain-Charles-Le Moyne, Saint-Hubert, Quebec, Canada
  1. Correspondence to Dr Maximilien Barret, Gastroenterology and Digestive Oncology, Hopital Cochin, Paris 75014, France; maximilien.barret{at}aphp.fr

Abstract

Objective Due to an annual progression rate of Barrett’s oesophagus (BO) with low-grade dysplasia (LGD) between 9% and 13% per year endoscopic ablation therapy is preferred to surveillance. Since this recommendation is based on only one randomised trial, we aimed at checking these results by another multicentre randomised trial with a similar design.

Design A prospective randomised study was performed in 14 centres comparing radiofrequency ablation (RFA) (maximum of 4 sessions) to annual endoscopic surveillance, including patients with a confirmed diagnosis of BO with LGD. Primary outcome was the prevalence of LGD at 3 years. Secondary outcomes were the prevalence of LGD at 1 year, the complete eradication of intestinal metaplasia (CE-IM) at 3 years, the rate of neoplastic progression at 3 years and the treatment-related morbidity.

Results 125 patients were initially included, of whom 82 with confirmed LGD (76 men, mean age 62.3 years) were finally randomised, 40 patients in the RFA and 42 in the surveillance group. At 3 years, CE-IM rates were 35% vs 0% in the RFA and surveillance groups, respectively (p<0.001). At the same time, the prevalence LGD was 34.3% (95% CI 18.6 to 50.0) in the RFA group vs 58.1% (95% CI 40.7 to 75.4) in the surveillance group (OR=0.38 (95% CI 0.14 to 1.02), p=0.05). Neoplastic progression was found in 12.5% (RFA) vs 26.2% (surveillance; p=0.15). The complication rate was maximal after the first RFA treatment (16.9%).

Conclusion RFA modestly reduced the prevalence of LGD as well as progression risk at 3 years. The risk-benefit balance of endoscopic ablation therapy should therefore be carefully weighted against surveillance in patients with BO with confirmed LGD.

Trial registration number NCT01360541.

  • Barrett's oesophagus
  • endoscopic procedures
  • dysplasia
  • oesophageal cancer

Data availability statement

Data are available on reasonable request.

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Data availability statement

Data are available on reasonable request.

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Footnotes

  • FP and SC are joint senior authors.

  • FP and SC contributed equally.

  • Contributors MB: acquisition of data; analysis and interpretation of data; drafting of the manuscript. MP: acquisition of data; critical revision of the manuscript for important intellectual content. BT: study concept and design; acquisition of data; analysis and interpretation of data; critical revision of the manuscript for important intellectual content. TP: acquisition of data; critical revision of the manuscript for important intellectual content. FCh: acquisition of data; critical revision of the manuscript for important intellectual content. GR: acquisition of data; critical revision of the manuscript for important intellectual content. MLR: acquisition of data; critical revision of the manuscript for important intellectual content. ECo: acquisition of data; critical revision of the manuscript for important intellectual content. MG: acquisition of data; critical revision of the manuscript for important intellectual content. FCa: acquisition of data; critical revision of the manuscript for important intellectual content. CB: acquisition of data; critical revision of the manuscript for important intellectual content. RL: acquisition of data; critical revision of the manuscript for important intellectual content. RLe: acquisition of data; critical revision of the manuscript for important intellectual content. JJ: acquisition of data; critical revision of the manuscript for important intellectual content. FZ: acquisition of data; critical revision of the manuscript for important intellectual content. ECh: acquisition of data; critical revision of the manuscript for important intellectual content. EM-C: acquisition of data; critical revision of the manuscript for important intellectual content. JE: acquisition of data; critical revision of the manuscript for important intellectual content. GV: acquisition of data; critical revision of the manuscript for important intellectual content. JB: acquisition of data; critical revision of the manuscript for important intellectual content. PB: acquisition of data; critical revision of the manuscript for important intellectual content. LJ: acquisition of data; analysis and interpretation of data; critical revision of the manuscript for important intellectual content. HA: study concept and design; acquisition of data; analysis and interpretation of data; critical revision of the manuscript for important intellectual content. NK: acquisition of data; critical revision of the manuscript for important intellectual content. SL: acquisition of data; critical revision of the manuscript for important intellectual content. MBe: study concept and design; critical revision of the manuscript for important intellectual content. FP: study concept and design; study supervision; obtained funding; acquisition of data; critical revision of the manuscript for important intellectual content. SC: study concept and design; obtained funding; critical revision of the manuscript for important intellectual content.

  • Funding This study was funded by the Programme Hospitalier de Recherche Clinique 2009 and the French Ministry of Health (PHRC 00-89). This work was led under scientific caution of the Société Française d’Endoscopie Digestive (French Digestive Endoscopy Society).

  • Competing interests MBa: Norgine (consulting), Medtronic (teaching), 3D Matrix (research grant). MP: Norgine (consulting), 3D matrix (consulting), Boston Scientific (consulting), Cook Medical (training). ECo: AbbVie (teaching), Fujifilm (consulting), Mayoly-Spindler (teaching), Medtronic (consulting), Norgine (consulting). CB: Boston Scientific (consulting), Recordati (teaching), Norgine (teaching). FZ: Medtronic (research grant), Reckitt Benckiser (consulting).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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