The 360 Express RFA balloon catheter (“360 Express”) for radiofrequency ablation (RFA) of Barrett’s esophagus (BE) has the ability to self-adjust to the esophageal lumen ensuring optimal tissue contact during ablation. Aim of this randomized clinical trial was to compare three different ablation regimens for treatment of BE using the 360 Express. Patients with a 2-15 cm BE with low-grade dysplasia (LGD), high-grade dysplasia (HGD) or early cancer (EC) were included. Visible lesions were removed by endoscopic resection (ER) prior to RFA. Patients were randomly assigned on a 1:1:1 ratio to the standard (1x10J/cm2-clean-1x10J/cm2), simple-double (2x10J/cm2-no clean), or simple-single ablation regimen (1x10J/cm2-no clean). Sample size calculation showed that 36 patients would be necessary in each arm. Primary outcome: percentage of endoscopically visual surface regression of BE at 3 months as scored by two independent blinded endoscopists. Secondary outcomes: adverse events and procedure time. Inclusion started September 2015 and was completed by October 2017. A total of 103 patients (81 male, median 66 yrs, median C4M7 BE) were included. Forty-three patients underwent ER prior to RFA (EC, n=22; HGD, n=13; LGD, n=6, non-dysplastic IM, n=2). Worst histology prior to RFA: HGD, n=42; LGD, n=51; non-dysplastic IM, n=10. In February 2017, after 28 patients were included in the simple-double arm, further inclusion in this arm was stopped because of an unexpected high risk of severe stenosis. Six patients developed a stenosis (21%, 95% CI:10-39%) requiring a median of 6 dilations after simple-double ablation. The study was continued with the standard and simple-single arm. To date, a total of 90/103 patients have completed the study (standard, n=31/37; simple-single, n=31/38, simple-double, n=28/28). Median BE regression was higher in the standard arm compared to the simple-single regimen: 85% (IQR 75-94), 95% CI:78-92% versus 73% (IQR 48-90), 95% CI:59-85%( p0.009). A poor response (defined as ≤50% regression) was found in 3/31 and in 9/31 patients in respectively the standard and simple-single arm (p0.05). The standard ablation procedure was significantly longer: median 31mins (IQR 26-36) versus 17mins (IQR 13-20), p<0.001. Adverse events occurred in 5/37 patients in the standard arm (minor laceration n=4, unrelated death n=1) and in 5/38 patients in the simple-single arm (minor laceration n=3, minor bleeding n=1, pain and fever n=1). Results of this randomized controlled trial suggest that c-RFA with the 360 Express using the standard regimen results in significant better regression after one treatment session compared with the simple-single regimen. However, the procedure is longer when using the standard regimen. The simple-double ablation regimen is not advised given the unacceptable risk of severe stenosis.Table 1Baseline characteristicsAblation regimenStandardSimple-singleSimple-double (arm early closed)Patients, (n)373828Male: female29:828:1024:4Median age, years (IQR)65 (61-72)67 (62-69)67 (61-70)Median BE, cm (IQR)C4 (2-7) M7 (5-10)C6 (2-7) M8 (5-10)C4 (1-5) M6 (4-8)Worst overall histological diagnosis prior to treatment (biopsies or ER specimens), n (%)LGD11 (30)15 (39)11 (39)HGD17 (46)15 (39)11 (39)EC9 (24)8 (22)6 (22)ER prior to RFA, n (%)15 (41)16 (42)12 (43) Open table in a new tab Table 2OutcomesAblation regimenStandardSimple-singleSimple-double (arm early closed)Median BE regression, % (IQR)85 (75-94)95% CI: 78%-92%73 (48-90)95% CI: 59% - 85%88 (81-93)95% CI: 83% - 92%Patients with a poor regression response (≤50% BE regression), n (%)3 (10)9 (29)0 (0)Median procedure duration, min (IQR)31 (26-36)17 (13-20)17 (14-20)Overall adverse event rate5 (14)5 (13)7 (25)- Stricture requiring an intervention, n (%)0 (0)0 (0)6 (21)Mild n=1; Moderate n=1, Severe n=4- Minor laceration, n (%)4 (11)3 (8)0 (0)- Other adverse events, n (%)Unrelated death: 1 (3)Minor bleeding: 1 (3)Pain and fever: 1 (3)Near collaps: 1 (4) Open table in a new tab