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/moderate	170 (12 (11 to 14))
Severe	40 (3 (2 to 4))
Post-procedural bleed
Incidence, n (% (95% CI))	52 (4 (3 to 5))
Severity*, n (% (95% CI))
Mild	19 (1 (1 to 2))
Moderate	25 (2 (1 to 3))
Severe	8 (0.5 (0.3 to 1))
Cause, n
ER	29
RFA	23
Perforation
Incidence, n (% (95% CI))	11 (0.8 (0.4 to 1))
Severity*, n (% (95% CI))
Mild	5 (0.4 (0.1 to 0.9))
Moderate	6 (0.4 (0.2 to 1)
Severe	–
Cause, n
ER	6
Endoscopic dilatation	5

*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.