Table 3.
Outcomes of 360 Express procedure | |
Patients (n) | 30 |
Median percentage of Barrett's surface regression at three monthsa, % (IQR) | 90 (77–95) |
Median total procedure time, min (IQR) | 31 (28–38) |
Median ablation time, min (IQR) | 20 (17–25) |
Adverse events of self-sizing session, n (%) | 4 (13) |
Mild adverse events | 3 |
- acute laceration | |
- early atrial fibrillation | |
- late dysregulation of diabetes mellitus | |
Moderate complication | 1 |
- early dysphagia, no endoscopic esophageal abnormalities | |
Outcomes of entire treatment phase | |
Patients (n) | 30 |
Stenosis at any point during treatment phase requiring intervention, n (%) | 3 (10) |
Complete eradication of dysplasia at end of the treatment phase, n (%) | |
- Intention to treat analysis | 29/30 (97) |
- Per protocol analysis | 28/28 (100) |
Complete eradication of intestinal metaplasia at end of the treatment phase | |
- Intention to treat analysis | 26/30 (87) |
- Per protocol analysis | 26/28 (93) |
Median total number of treatment sessionsb per patient, (IQR) | 3 (IQR 2–4) |
Number of circumferential RFA sessions per patient, n | 1 |
Median number of focal RFA sessions per patient, (IQR) | 1 (1–2) |
Number of patients who underwent APCc, n | 13 |
- One session | 8 |
- Two sessions | 5 |
Number of patients who underwent EMR, n | |
- Escape treatment for residual IM after RFA (n = 1) | 2 |
- Diagnosis of elevated BE islands (n = 1)d |
Mean of two independent scores by expert endoscopists.
Treatment sessions included circumferential RFA, focal RFA, APC and EMR.
APC was used to treat small areas of Barrett's mucosa (islands/tongues < 10 mm).
Histology showed non-dysplastic IM.
APC: argon plasma coagulation; BE: Barrett's esophagus; EMR: endoscopic mucosal resection; IM: intestinal metaplasia; IQR: interquartile range; min: minutes; n: number of patients; RFA: radiofrequency ablation.