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DOI: 10.1055/s-0044-1783180
Endoscopic radiofrequency ablation versus hybrid argon plasma coagulation in the treatment of Barrett's esophagus – the patients' perspective: a randomized controlled trial assessing procedural acceptability and safety (the RATE study)
Aims Endoscopic radiofrequency ablation (RFA) and argon plasma coagulation (APC) are established ablation techniques in the treatment of Barrett's esophagus (BE). Currently, a modification of the APC method involving submucosal injection of saline preceding the thermal ablation (hybrid-APC) has become available. Both RFA and h-APC are highly effective in eradicating BE, but data comparing the patient-related outcomes of these procedures remain limited. We aimed to evaluate the acceptability, safety, and impact on the patient’s quality of life of these two methods.
Methods In this prospective single-blinded randomized-controlled trial, consecutive adult patients requiring ablative treatment for BE were enrolled to receive either RFA or h-APC. For each ablation, we recorded the procedural time, as well as the level of post-procedural chest pain, the degree of dysphagia, and the esophageal-specific quality of life through a numeric analog scale (NAS), the Mellow-Pinkas scoring system, and validated QLQ-OES18 questionnaire, respectively. Those outcomes were evaluated before and after each procedure, on day 7, and day 30. The results were then compared between the two modalities using the Wilcoxon rank-sum test. Adverse events (AEs) were actively monitored, classified accordingly with the AGREE classification, and compared using the chi-square test.
Results Overall, we analyzed 69 ablation procedures (32 RFA[46.4%]; 37 h-APC[53.6%]) performed in 39 patients (33 males [84.6%]; mean age 62.1[±11.7] yrs.) with a median BE segment length of C0M3 (C-IQR: 0-3.5, M-IQR: 2-7). Twenty-one patients (53.8%) underwent previous endoscopic resection for a visible dysplastic lesion. The remaining 18 patients had confirmed low-grade dysplasia (LGD) without visible lesion. The maximum BE grades included: 5 pT1 adenocarcinomas (EACs; 12.8%), 18 high-grade dysplasia (HGD; 46.2%), and 16 low-grade dysplasia (LGD; 41.0%). The mean procedure time for h-APC and RFA was 12.9 (±6.37) and 9.12 (±4.93) minutes, respectively (P=.003). Both NAS pain scores and dysphagia degree at day 7 post-procedure were significantly higher for the RFA as compared to h-APC (5 [IQR 0-7] vs. 1 [0-4], P=.010), respectively. On day 30 after the procedure, these metrics decreased to a median value of 0, both for RFA and h-APC. There was no significant difference in the QLQ scores between groups, neither before nor at any time point after the procedure. Major AEs included 3 strictures (15.8%) in the RFA group, as compared to 1 stricture within the h-APC group (5.0%; P=.560). [1] [2]
Conclusions Despite a shorter procedural time, RFA carries a higher burden of post-ablation chest pain and degree of dysphagia within the first week after the procedure, as compared to h-APC. These symptoms are intermittent and seem to resolve completely in both treatment groups on day 30 after treatment.
Publication History
Article published online:
15 April 2024
© 2024. European Society of Gastrointestinal Endoscopy. All rights reserved.
Georg Thieme Verlag KG
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References
- 1 Nass KJ, Zwager LW, van der Vlugt M. et al. Novel classification for adverse events in GI endoscopy: the AGREE classification. Gastrointest Endosc 2022; 95: 1078-1085
- 2 Weusten BLAM, Bisschops R, Dinis-Ribeiro M. et al. Diagnosis and management of Barrett esophagus: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2023