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DOI: 10.1055/s-0040-1704366
ENDOSCOPIC RADIOFREQUENCY ABLATION OR SURVEILLANCE OF BARRET’S ESOPHAGUS WITH LOW GRADE DYSPLASIA: A FRENCH MULTICENTER RANDOMIZED TRIAL
Publication History
Publication Date:
23 April 2020 (online)
Aims Recent studies have suggested an annual neoplastic progression rate of Barrett’s esophagus (BE) containing low grade dysplasia (LGD) of 9 to 13%, leading to consider endoscopic ablation therapy rather than surveillance. We aimed to compare radiofrequency ablation (RFA) to endoscopic surveillance in the management of BE containing LGD.
Methods This is a prospective multicenter randomized study comparing RFA (up to 4 sessions every 2 months) to a yearly endoscopic surveillance. Inclusion criteria were the presence of a C >1 or M> 2 BE with intestinal metaplasia and LGD confirmed by an expert central pathologist. The main judgement criteria was the rate of LGD at 3 years, and the secondary judgement criteria were the rates of complete remission of intestinal metaplasia (CRIM), neoplastic progression at 3 years, and treatment morbidity.
Results 125 patients were included and 82 randomized, 40 in the RFA and 42 in the surveillance arm. The median (IQR) number of RFA sessions was 3 (2-4). In intention to treat, the 3-year prevalence of LGD was 34.3% [18.6-50.0] in the RFA group and 58.1% [40.7-75.4] in the surveillance group, OR = 0.38 [0.14-1.02], p= 0.05. The 3-year CRIM was 30% [15.8-44.2] vs. 0, p< 0.001 in the RFA and surveillance arms, respectively. The 3-year neoplastic progression rate was 13.5% in the RFA group and 27.5% in the surveillance group, p= 0.15. The complication rate was maximal after the first RFA treatment (16.9%) and diminished with the treatment sessions.
Conclusions A spontaneous regression of LGD on BE occurred in more than 40% of the patients in the surveillance group at three years. The 30% rate of CRIM, lower than reported in the literature, might explain the absence of significantly different 3-year neoplastic progression rates among the groups. Further analyses are needed to determine the factors associated with the CRIM failures.
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