Table 2

Safety outcomes

Total patients
N=1386
At least 1 complication, n (% (95% CI))268 (21 (19 to 23))
Stenosis
Incidence, n (% (95% CI))210 (15 (13 to 17))
Severity*, n (% (95% CI))
 Mild/moderate170 (12 (11 to 14))
 Severe40 (3 (2 to 4))
Post-procedural bleed
Incidence, n (% (95% CI))52 (4 (3 to 5))
Severity*, n (% (95% CI))
 Mild19 (1 (1 to 2))
 Moderate25 (2 (1 to 3))
 Severe8 (0.5 (0.3 to 1))
Cause, n
 ER29
 RFA23
Perforation
Incidence, n (% (95% CI))11 (0.8 (0.4 to 1))
Severity*, n (% (95% CI))
 Mild5 (0.4 (0.1 to 0.9))
 Moderate6 (0.4 (0.2 to 1)
 Severe
Cause, n
 ER6
 Endoscopic dilatation5
  • *Adverse events were graded as ‘mild’ (unplanned hospital admission, hospitalisation <3 days, haemoglobin drop <3 g, no transfusion), ‘moderate’ (4–10 days hospitalisation,<4 units blood transfusion, repeat endoscopic intervention, radiological intervention), ‘severe’ (hospitalisation >10 days, intensive care unit (ICU) admission, need for surgery, >4 units blood transfusion, in the case of stenosis: >5 dilatations, stent placement or incision therapy) or ‘fatal’ (death attributable to procedure <30 days or longer with continuous hospitalisation). See online supplemental table S2 for more definitions.

  • ER, Endoscopic resection; RFA, Radiofrequency ablation.