BACKGROUND & AIMS: The current procedure for circumferential balloon-based radiofrequency ablation (c-RFA) for the removal of dysplastic Barrett's esophagus (BE) is labor intensive, comprising 2 ablation passes with a cleaning step to remove debris from the ablation zone and electrode. We compared the safety and efficacy of 3 different c-RFA ablation regimens. METHODS: We performed a prospective trial of consecutive patients with flat-type BE with high-grade dysplasia. Fifty-seven patients (45 men; age, 64 ± 15 y; 28 with prior endoscopic resection) were assigned randomly to groups that underwent c-RFA with a double application of RFA (12 J/cm(2)). The standard group received c-RFA, with device removal and cleaning, followed by c-RFA; the simple-with-cleaning group underwent c-RFA, with device cleaning without removal, followed by c-RFA; and the simple-no-cleaning group received 2 applications of c-RFA, and the device was not removed or cleaned. The primary outcome was surface regression of BE 3 months later, graded by 2 blinded expert endoscopists. Calculated sample size was 57 patients, based on a noninferiority design. RESULTS:Median BE surface regression at 3 months was 83% in the standard group, 78% in the simple-with-cleaning group, and 88% in the simple-no-cleaning group (P = .14). RF ablation time was 20 minutes (interquartile range [IQR], 18-25 min) for the standard group, 13 minutes (IQR, 11-15 min) for the simple-with-cleaning group, and 5 minutes (IQR, 5-9 min) for the simple-no-cleaning group (P < .01). The median number of introductions (RFA devices/endoscope) for the standard group was 7, vs 4 for the simple groups (P < .01). CONCLUSIONS: This randomized, prospective study suggests that c-RFA is easier and faster, but equally safe and effective, when the cleaning phase between ablations is omitted or simplified. Trialregister.nl, NTR 2495.
RCT Entities:
BACKGROUND & AIMS: The current procedure for circumferential balloon-based radiofrequency ablation (c-RFA) for the removal of dysplastic Barrett's esophagus (BE) is labor intensive, comprising 2 ablation passes with a cleaning step to remove debris from the ablation zone and electrode. We compared the safety and efficacy of 3 different c-RFA ablation regimens. METHODS: We performed a prospective trial of consecutive patients with flat-type BE with high-grade dysplasia. Fifty-seven patients (45 men; age, 64 ± 15 y; 28 with prior endoscopic resection) were assigned randomly to groups that underwent c-RFA with a double application of RFA (12 J/cm(2)). The standard group received c-RFA, with device removal and cleaning, followed by c-RFA; the simple-with-cleaning group underwent c-RFA, with device cleaning without removal, followed by c-RFA; and the simple-no-cleaning group received 2 applications of c-RFA, and the device was not removed or cleaned. The primary outcome was surface regression of BE 3 months later, graded by 2 blinded expert endoscopists. Calculated sample size was 57 patients, based on a noninferiority design. RESULTS: Median BE surface regression at 3 months was 83% in the standard group, 78% in the simple-with-cleaning group, and 88% in the simple-no-cleaning group (P = .14). RF ablation time was 20 minutes (interquartile range [IQR], 18-25 min) for the standard group, 13 minutes (IQR, 11-15 min) for the simple-with-cleaning group, and 5 minutes (IQR, 5-9 min) for the simple-no-cleaning group (P < .01). The median number of introductions (RFA devices/endoscope) for the standard group was 7, vs 4 for the simple groups (P < .01). CONCLUSIONS: This randomized, prospective study suggests that c-RFA is easier and faster, but equally safe and effective, when the cleaning phase between ablations is omitted or simplified. Trialregister.nl, NTR 2495.
Authors: Durayd Alzoubaidi; Krish Ragunath; Sachin Wani; Ian D Penman; Nigel John Trudgill; Marnix Jansen; Matthew Banks; Pradeep Bhandari; Allan John Morris; Robert Willert; Phil Boger; Howard L Smart; Narayanasamy Ravi; Jason Dunn; Charles Gordon; Jayan Mannath; Inder Mainie; Massi di Pietro; Andrew M Veitch; Sally Thorpe; Cormac Magee; Martin Everson; Sarmed Sami; Paul Bassett; David Graham; Stephen Attwood; Oliver Pech; Prateek Sharma; Laurence B Lovat; Rehan Haidry Journal: Frontline Gastroenterol Date: 2019-08-14
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Authors: K Belghazi; R E Pouw; Cmt Sondermeijer; S L Meijer; E J Schoon; A D Koch; Blam Weusten; Jjghm Bergman Journal: United European Gastroenterol J Date: 2018-04-11 Impact factor: 4.623
Authors: Cormac G Magee; David Graham; Charles Gordon; Jason Dunn; Ian Penman; Robert Willert; Howard Smart; Jacobo Ortiz-Fernandez-Sordo; Krish Ragunath; Martin Everson; Durayd Alzoubaidi; Matthew Banks; Danielle Morris; Sarmed Sami; Allan J Morris; Pradeep Bhandari; Ravi Narayanasamy; Massimiliano Di Pietro; Laurence B Lovat; Rehan Haidry Journal: Surg Endosc Date: 2021-02-05 Impact factor: 4.584