5 Safety

5 Safety

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 Ulceration (1 superficial ulcer and 1 bleeding ulcer) was reported in 10% (2/21) of patients in a case series of 21 patients with gastric antral vascular ectasia (GAVE) refractory to argon plasma coagulation therapy. Both ulcers resolved without intervention. The ulcers occurred in 2 of the first 3 patients in the series who were treated using 4 pulses per location. From the fourth patient onwards, a 2‑pulse‑per‑location protocol was used. A superficial ulcer was detected in 1 patient at endoscopic follow‑up 4–6 weeks after the last radiofrequency ablation (RFA) session in a case series of 6 patients with GAVE (no further details provided).

5.2 A submucosal tear at the gastro‑oesophageal junction was revealed by repeat endoscopy in 1 patient with alcohol‑induced cirrhosis and gastrointestinal bleeding from GAVE in a single case report. Dislodgement of the device probe from the endoscope may have caused the tear, which healed within 1 month.

5.3 Gastric inflammatory hyperplastic polyps in the distal body and antrum were detected at a fourth RFA session in 1 patient with hepatitis C and GAVE, in a single case report. The polyps were removed using heat cautery polypectomy (no further details provided).

5.4 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 did not list any anecdotal adverse events. They considered that the following were theoretical adverse events: stricture, perforation, bleeding and abdominal pain.

  • National Institute for Health and Care Excellence (NICE)