BACKGROUND: The currently recommended regimen for focal radiofrequency ablation (RFA) of Barrett's esophagus (BE) comprises 2 applications of energy, cleaning of the device and ablation zone, and 2 additional applications of energy. A simplified regimen may be of clinical utility if it is faster, easier, and equally safe and effective. OBJECTIVE: To compare the efficacy of 2 focal RFA regimens. SETTING: Three tertiary referral centers. PATIENTS: Consecutive patients scheduled for focal RFA of BE with flat type BE with at least 2 BE islands or mosaic groups of islands were enrolled. INTERVENTIONS: BE areas were paired: 1 area was randomized to the "standard" regimen (2 × 15 J/cm(2)-clean-2 × 15 J/cm(2)) or to the "simplified" regimen (3 × 15 J/cm(2)-no clean), allocating the second area automatically to the other regimen. The percentage of surface area regression of each area was scored at 2 months by the endoscopist (blinded). OUTCOME MEASURE: Proportion of completely removed BE areas at 2 months. Calculated sample size was 46 pairs of BE areas using a noninferiority design. Noninferiority was defined as <20% difference in the paired proportions. RESULTS:Forty-five equivalent pairs of BE areas were included in 41 patients. The proportion of completely removed BE areas at 2 months after focal RFA was 30 (67%) for standard and 33 (73%) for simplified. Noninferiority was demonstrated by a 7% difference (95% CI, -10.6 to +20.9). LIMITATIONS: Tertiary referral centers. CONCLUSIONS: The results of this multicenter randomized trial suggest that a simplified 3 × 15 J/cm(2) focal ablation regimen is not inferior to the standard regimen, regarding the endoscopic removal of residual Barrett islands.
RCT Entities:
BACKGROUND: The currently recommended regimen for focal radiofrequency ablation (RFA) of Barrett's esophagus (BE) comprises 2 applications of energy, cleaning of the device and ablation zone, and 2 additional applications of energy. A simplified regimen may be of clinical utility if it is faster, easier, and equally safe and effective. OBJECTIVE: To compare the efficacy of 2 focal RFA regimens. SETTING: Three tertiary referral centers. PATIENTS: Consecutive patients scheduled for focal RFA of BE with flat type BE with at least 2 BE islands or mosaic groups of islands were enrolled. INTERVENTIONS: BE areas were paired: 1 area was randomized to the "standard" regimen (2 × 15 J/cm(2)-clean-2 × 15 J/cm(2)) or to the "simplified" regimen (3 × 15 J/cm(2)-no clean), allocating the second area automatically to the other regimen. The percentage of surface area regression of each area was scored at 2 months by the endoscopist (blinded). OUTCOME MEASURE: Proportion of completely removed BE areas at 2 months. Calculated sample size was 46 pairs of BE areas using a noninferiority design. Noninferiority was defined as <20% difference in the paired proportions. RESULTS: Forty-five equivalent pairs of BE areas were included in 41 patients. The proportion of completely removed BE areas at 2 months after focal RFA was 30 (67%) for standard and 33 (73%) for simplified. Noninferiority was demonstrated by a 7% difference (95% CI, -10.6 to +20.9). LIMITATIONS: Tertiary referral centers. CONCLUSIONS: The results of this multicenter randomized trial suggest that a simplified 3 × 15 J/cm(2) focal ablation regimen is not inferior to the standard regimen, regarding the endoscopic removal of residual Barrett islands.
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
Authors: Wei Keith Tan; Krish Ragunath; Jonathan R White; Jose Santiago; Jacobo Ortiz Fernandez-Sordo; Mirela Pana; Bincy Alias; Andreas V Hadjinicolaou; Vijay Sujendran; Massimiliano di Pietro Journal: Endosc Int Open Date: 2020-01-22
Authors: Mate Knabe; Torsten Beyna; Thomas Rösch; Jacques Bergman; Hendrik Manner; Andrea May; Guido Schachschal; Horst Neuhaus; Jennis Kandler; Bas Weusten; Oliver Pech; Siegbert Faiss; Mario Anders; Michael Vieth; Susanne Sehner; Raf Bisschops; Pradeep Bhandari; Christian Ell; Hanno Ehlken Journal: Am J Gastroenterol Date: 2022-01-01 Impact factor: 12.045
Authors: Wei Keith Tan; Arti Rattan; Maria O'Donovan; Tara Nuckcheddy; Bincy Alias; Vijay Sujendran; Massimiliano di Pietro Journal: United European Gastroenterol J Date: 2018-01-17 Impact factor: 4.623
Authors: Udayakumar Navaneethan; Nirav Thosani; Adam Goodman; Michael Manfredi; Rahul Pannala; Mansour A Parsi; Zachary L Smith; Shelby A Sullivan; Subhas Banerjee; John T Maple Journal: VideoGIE Date: 2017-09-28
Authors: M J van der Wel; L C Duits; E Klaver; R E Pouw; C A Seldenrijk; Gja Offerhaus; M Visser; Fjw Ten Kate; J G Tijssen; Jjghm Bergman; S L Meijer Journal: United European Gastroenterol J Date: 2018-03-07 Impact factor: 4.623