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 Oesophageal perforation (severity not stated) was reported in 27% (6/22) of patients in a case series of 22 patients (method of diagnosis not described). This was managed conservatively; 4 patients were hospitalised for 3–5 days and 2 were observed overnight. Perforation (confirmed by endoscopy) was reported in 1 patient in a case series of 41 patients: the patient was tube fed for 7 days and had antibiotic therapy for 10 days, leading to complete resolution. Macroscopic perforations were reported in 11% (3/28) of patients treated by cap‑assisted flexible endoscopic treatment in a case series of 39 patients: these were immediately closed using endoclips. Suspected perforation was reported in 2% (3/150) of patients in a case series of 150 patients; the patients had increased C‑reactive protein levels and fever. With conservative management their symptoms and signs resolved within 2–14 days.
5.2 Bleeding was reported in 2% (2/125) of patients in a case series of 125 patients (not further described). Bleeding that needed transfusion was reported in 1 patient in a case series of 42 patients; this was treated by endoscopic injection of an adrenaline solution.
5.3 A neck abscess developed 1 week after treatment in 1 patient in the case series of 22 patients. This was drained surgically and the patient stayed in hospital for 9 days.
5.4 Infection with fever lasting more than 24 hours was reported in 10% (4/41) of patients in the case series of 41 patients. Antibiotics were given and perforation and mediastinitis were excluded by diagnostic tests.
5.5 Aspiration pneumonia after extubation was reported in 1 patient in the case series of 150 patients.
5.6 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers considered that the following were theoretical adverse events: septicaemia, death.