Self-sizing radiofrequency ablation balloon for eradication of Barrett's esophagus: results of an international multicenter randomized trial comparing 3 different treatment regimens

      Background and Aims

      Recently, the 360 Express radiofrequency ablation balloon catheter (360 Express, Medtronic, Minneapolis, Minn, USA) has replaced the traditional system for circumferential radiofrequency ablation (RFA) of Barrett’s esophagus (BE). The aim was to compare 3 different ablation regimens for the 360 Express.

      Methods

      An international multicenter noninferiority randomized controlled trial was conducted in which patients with a BE (2-15 cm) with dysplasia or early cancer were randomly assigned to the standard (1 × 10 J/cm2-clean-1 × 10 J/cm2), simple-double (2 × 10 J/cm2-no clean), or simple-single ablation regimen (1 × 10 J/cm2-no clean). The primary outcome was the percentage endoscopically visual BE regression at 3 months. Secondary outcomes were procedure time, adverse events, and patient discomfort.

      Results

      Between September 2015 and October 2017, 104 patients were enrolled. The simple-double ablation arm was closed prematurely because of a 21% stenosis rate. The trial continued with the standard (n = 37) and simple-single arm (n = 38). Both arms were comparable at baseline. Noninferiority of the simple-single arm could not be demonstrated: BE regression was 73% in the simple-single arm versus 85% in the standard arm; the median difference was 13% (95% confidence interval, 5%-23%). The procedure time was significantly longer in the standard arm (31 vs 17 minutes, P < .001). Both groups were comparable with regard to adverse events and patient discomfort.

      Conclusions

      This randomized trial shows that circumferential RFA with the 360 Express using the simple-double ablation regimen results in an unacceptable high risk of stenosis. Furthermore, the results suggest that a single ablation at 10 J/cm2 results in inferior BE regression at 3 months. We therefore advise using the standard ablation regimen (1 × 10 J/cm2-clean-1 × 10 J/cm2) for treatment of BE using the 360 Express. (Clinical trial registration number: NTR5191.)

      Abbreviations:

      360 Express (360 Express RFA balloon catheter), BE (Barrett’s esophagus), CI (confidence interval), DSMB (data and safety monitoring board), EID (esophageal inner diameter), ER (endoscopic resection), m-ITT (modified intention-to-treat), IQR (interquartile range), MEC (Medical Ethical Committee), RFA (radiofrequency ablation), SD (standard deviation), WLE (white-light endoscopy)
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