3.1 To inform the committee, NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 9 sources, which was discussed by the committee. The evidence included 1 randomised controlled trial, 1 systematic review, 4 non-randomised comparative studies (3 of which are also included in the systematic review), and 3 case series (2 of which are also included in the systematic review), and is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: improved quality of life, relief of jaundice, relief of biliary obstruction, reduced stricture and improved survival.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: bleeding, liver infarction, infection, pancreatitis, cholangitis and biliary leakage.
3.4 Patient commentary was sought but none was received.