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 overview.
5.1 Death within 90 days was reported in 10% (2/21) of patients in a case series of 22 patients. One patient died after biliary decompression by self-expandable metal stent placement could not be achieved and the other patient died as a result of disease progression with a patent stent.
5.2 A hepatic artery pseudoaneurysm, arising from the central right hepatic artery, occurred in 1 patient who underwent endoscopic retrograde cholangiopancreatography (ERCP) with radiofrequency ablation catheter treatment in the right hepatic duct, left hepatic duct and the common hepatic duct biliary confluence. It was unclear if the aneurysm was partially or completely within the liver. Treatment with embolisation successfully stopped the haemorrhage and the patient recovered. This adverse event was reported in the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.
5.3 Asymptomatic biochemical pancreatitis developed after ERCP in 1 patient in the case series of 22 patients.
5.4 Cholecystitis needing percutaneous gallbladder drainage was reported in 10% (2/21) of patients in the case series of 22 patients. Both patients had tumour encasement of the cystic duct and sepsis before ERCP.
5.5 The specialist advisers listed additional anecdotal events as cholangitis and probe breakage inside the patient, and theoretical adverse events as cholangitis, stent occlusion, damage to surrounding tissues, perforation of bile duct, biliary leak, abscess formation and portal vein thrombosis.