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 11 sources, which was discussed by the committee. The evidence included 3 systematic reviews and meta-analyses and 7 case series (including safety data from 2 conference abstracts), and is presented in table 2 of the interventional procedures overview. It also considered data provided by the selective internal radiation therapy Commissioning through Evaluation registry study. 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: quality of life, survival, downstaging to allow surgical resection and reduction in tumour size.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: bleeding, infection, unintended radiation toxicity and hepatic failure.
3.4 Patient commentary was sought but none was received.
3.5 There are different types of microspheres used. There are also different types of radionuclides used, but all the evidence considered included studies using yttrium.
3.6 The committee was told that dosimetry in this procedure is complex and needs significant expertise.
3.7 The committee was told that the companies provide comprehensive training for the procedure.
3.8 The committee did not see any evidence to suggest that there is improved survival in patients in whom the procedure has made subsequent surgical resection possible.
3.9 The committee noted that transient side effects after this procedure are common.
3.10 The committee noted that this procedure has been available since 2002.
3.11 Primary intrahepatic cholangiocarcinoma is a rare condition with a limited life expectancy.