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)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: May 17, 2019
Accepted:
May 12,
2019
Received:
March 29,
2019
Footnotes
If you would like to chat with an author of this article, you may contact Dr Bergman at [email protected]
DISCLOSURE: Dr Koch has received research support from Cook Medical and Interscope and speaker and consultancy fees from ErbeElektromedizin. Dr Weusten has received research support and speaker fees from Pentax Medical. Dr Schoon has received speaker and consultancy fees from Medtronic, Boston Scientific, and Olympus, and research support from Fujifilm. Dr Haidry has received research support from Cook Medical, Pentax Europe, Medtronic, Beamline Technologies, and C2 Therapeutics. Dr Pech has received speaker fees from Medtronic, Olympus, Fujifilm, Boston Scientific, Falk, AbbVie, Bristol Myers Squibb, and Creo Medical. Dr Bergman has received research support from Medtronic, Olympus Endoscopy, Cook Medical, Boston Scientific, Erbe Medical, C2 Therapeutic, and Ninepoint Medical, and consultancy fees from Cook Medical and Boston Scientific. Dr Bisschops has received research support from Pentax, Fujifilm, and Cook Medical, speaker fees from Medtronic and Pentax, and consultancy fees from Medtronic, Pentax, Fujifilm, and Boston Scientific. All other authors disclosed no financial relationships relevant to this publication.
See CME section, p. 506.
Identification
Copyright
© 2019 by the American Society for Gastrointestinal Endoscopy
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Access this article on ScienceDirectLinked Article
- Just relax: allowing the endoscopist and esophagus to “cool off” between radiofrequency ablation applications affects stricture formationGastrointestinal EndoscopyVol. 91Issue 2
- PreviewOptimizing procedural efficacy is critical, given the imbalance between the demand for and availability of endoscopic resources. This need precipitated the development of a simplified circumferential radiofrequency ablation (RFA) regimen for Barrett’s esophagus, whereby the cleaning phase between RFA applications is omitted. A simplified regimen, with the use of traditional RFA catheters, is as effective at reducing the burden of Barrett’s esophagus but with a significant reduction in procedural time.
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