Clinical trial on RFA in low grade dysplasia

Results from this clinical trial on RFA vs. annual surveillance in persons with low grade dysplasia were modestly supportive of RFA in this population, with a 62% reduction in prevalence of Barrett's after three years which was of borderline statistically significance. One or more adverse events were experience by 19% of the RFA group, while spontaneous regression of LGD was observed in almost 1/3 of the surveillance patients. The small size of the study is an important limitation which limits interpretation.

Gut. 2021 Mar 8;gutjnl-2020-322082.

doi: 10.1136/gutjnl-2020-322082. Online ahead of print.

Endoscopic radiofrequency ablation or surveillance in patients with Barrett's oesophagus with confirmed low-grade dysplasia: a multicentre randomised trial

Maximilien Barret  1 , Mathieu Pioche  2 , Benoit Terris  3 , Thierry Ponchon  4 , Franck Cholet  5 , Frank Zerbib  6 , Edouard Chabrun  6 , Marc Le Rhun  7 , Emmanuel Coron  7 , Marc Giovannini  8 , Fabrice Caillol  8 , René Laugier  9 , Jeremie Jacques  10 , Romain Legros  10 , Christian Boustiere  11 , Gabriel Rahmi  12 , Elodie Metivier-Cesbron  13 , Geoffroy Vanbiervliet  14 , Paul Bauret  15 , Jean Escourrou  16 , Julien Branche  17 , Lea Jilet  18 , Hendy Abdoul  18 , Nadira Kaddour  18 , Sarah Leblanc  19 , Michael Bensoussan  20 , Frederic Prat #  19 , Stanislas Chaussade

PMID: 33685969

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.

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