Article Text
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.
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.
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