Radiofrequency ablation compared with argon plasma coagulation after endoscopic resection of high-grade dysplasia or stage T1 adenocarcinoma in Barrett’s esophagus: a randomized pilot study (BRIDE) - 21/03/19
Abstract |
Background and Aims |
Endoscopic resection (ER) is safe and effective for Barrett’s esophagus (BE) containing high-grade dysplasia (HGD) or mucosal adenocarcinoma (T1A). The risk of metachronous neoplasia is reduced by ablation of residual BE by using radiofrequency ablation (RFA) or argon plasma coagulation (APC). These have not been compared directly. We aimed to recruit up to 100 patients with BE and HGD or T1A confirmed by ER over 1 year in 6 centers in a randomized pilot study.
Methods |
Randomization was 1:1 to RFA or APC (4 treatments allowed at 2-month intervals). Recruitment, retention, dysplasia clearance, clearance of benign BE, adverse events, healthcare costs, and quality of life by using EQ-5D, EORTC QLQ-C30, or OES18 were assessed up to the end of the trial at 12 months.
Results |
Of 171 patients screened, 76 were randomized to RFA (n = 36) or APC (n = 40). The mean age was 69.7 years, and 82% were male. BE was <5 cm (n = 27), 5 to 10 cm (n = 45), and >10 cm (n = 4). Sixty-five patients completed the trial. At 12 months, dysplasia clearance was RFA 79.4% and APC 83.8% (odds ratio [OR] 0.7; 95% confidence interval [CI], 0.2-2.6); BE clearance was RFA 55.8%, and APC 48.3% (OR 1.4; 95% CI, 0.5-3.6). A total of 6.1% (RFA) and 13.3% (APC) had buried BE glands. Adverse events (including stricture rate after starting RFA 3/36 [8.3%] and APC 3/37 [8.1%]) and quality of life scores were similar, but RFA cost $27491 more per case than APC.
Conclusion |
This pilot study suggests similar efficacy and safety but a cost difference favoring APC. A fully powered non-inferiority trial is appropriate to confirm these findings. (Clinical trial registration number: NCT01733719.)
Il testo completo di questo articolo è disponibile in PDF.Abbreviations : APC, BE, BRIDE, ER, HGD, IM, RCT, RFA
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| Disclosure: This article presents independent research funded by theNational Institute for Health Research(NIHR) under its Research for Patient Benefit Programme (grant no.PB-PG-0711-25066). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health. K. Ragunath received educational grants from Erbe and Medtronic. Rehan Haidry received research infrastructure support from Medtronic, Cook Endoscopy, and Pentax Europe. Laurence Lovat received research infrastructure support from Medtronic. All other authors disclosed no financial relationships relevant to this article. |
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| If you would like to chat with an author of this article, you may contact Dr de Caestecker at john.decaestecker@uhl-tr.nhs.uk. |
Vol 89 - N° 4
P. 680-689 - aprile 2019 Ritorno al numero
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