Pouw RE, et al. - In this randomised non-inferiority trial, the researchers intended to compare simplified regimen (3 × 15 J/cm², without cleaning) and standard regimen (2 × 15 J/cm², followed by cleaning, followed by 2 × 15 J/cm²) for focal radiofrequency ablation of dysplastic Barrett's oesophagus, as well as tested the premises that this new simplified regimen would be as effective and safe as the standard regimen. They discovered that the simplified regimen was the preferred regimen for focal radiofrequency ablation of Barrett's oesophagus.

Methods

• This trial involved subjects with dysplastic Barrett's oesophagus or residual Barrett's oesophagus after endoscopic resection or circumferential radiofrequency ablation, in five European tertiary referral centres.
• For this analysis, patients were randomly assigned (1:1) to the new simplified regimen (3 × 12 J/cm², without cleaning) or the standard regimen, with variable block sizes of four, six, and eight patients, stratified by participating hospital.
• Researchers performed focal radiofrequency ablation every 3 months, up to a maximum of three treatments, until all Barrett's oesophagus was eradicated.
• Complete endoscopic and histological regression of dysplasia and intestinal metaplasia after two focal radiofrequency ablation treatments was the primary outcome, assessed in the intention-to-treat population.
• They evaluated non-inferiority on the basis of the difference between groups in the median percentage of Barrett's oesophagus surface regression, with a non-inferiority margin of -15%.

Results

• Eighty-four patients were randomly assigned to treatment: 44 to receive the simplified regimen and 40 to receive the standard regimen between March 25, 2015, and July 25, 2016.
• One patient assigned to the simplified regimen and four assigned to the standard regimen were excluded because they were found not to be eligible.
• The final intention-to-treat population comprised of 43 patients in the simplified ablation group and 36 in the standard ablation group.
• It was observed that complete endoscopic and histological regression of dysplasia and intestinal metaplasia after two focal radiofrequency ablation treatments was achieved in 32 (74%, 95% CI 59–87) subjects treated with the simplified protocol, vs 30 (83%, 95% CI 67–94) subjects treated with the standard protocol (p=0·34).
• It was noted that median Barrett's oesophagus surface regression after two focal radiofrequency ablation sessions was 98% (IQR 95–100) in the simplified regimen group and 100% (97–100) in the standard regimen group.
• The findings demonstrated that the difference between medians was 2% (95% CI -0·562 to 3·162); thus the simplified regimen was deemed non-inferior to the standard regimen.
• Findings revealed that stenoses requiring dilatation were noted in four (9%) of 43 patients in the simplified regimen group and four (11%) of 36 in the standard regimen group.
• Data reported that post-procedural bleeding requiring repeat endoscopy occurred in one (2%) subject in the simplified ablation group and three (8%) subjects in the standard ablation group.
• Due to an unknown cause, one patient (2%) in the simplified treatment group died 36 days after the second radiofrequency ablation procedure.