This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
5.1 In a case series of 13 patients, 1 patient (with a narrowed oesophagus after endoscopic mucosal resection) had an oesophageal perforation and a mediastinal abscess that developed 2 days after dilation for stenosis, done 12 days after radiofrequency ablation. This was managed with a covered stent and percutaneous drainage. After removal of the stent, a further stenosis was observed that was treated by repeated dilatation, corticosteroid injection and incisional therapy.
5.2 Oesophageal strictures were reported after circumferential radiofrequency ablation in 20% (4/20) and 14% (4/29) of patients in a case series of 20 patients and a case series of 29 patients respectively. Two strictures (both related to endoscopic mucosal resection) were reported in 2 patients in the case series of 13 patients. All strictures in all these series resolved after 1 or more endoscopic dilations.
5.3 Mucosal laceration after sizing was reported in 1 patient in the case series of 29 patients and in 1 patient in the case series of 20 patients. Mucosal laceration (at the endoscopic resection scar) was reported in 2 patients in the case series of 13 patients. None of these lacerations needed treatment.
5.4 Submucosal haematoma (asymptomatic and needing no intervention) was reported in 1 patient in the case series of 13 patients.
5.5 The specialist advisers listed additional adverse events as complications of sedation, odynophagia, dysphagia, and chest and back pain.