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    3 Committee considerations

    The evidence

    3.1

    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 7 sources, which was discussed by the committee. The evidence included 5 randomised controlled trials, 1 non-randomised comparative study and 1 systematic review and meta-analysis. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in table 5 of the overview.

    3.2

    The professional experts and the committee considered the key efficacy outcomes to be: improvement in quality of life, reduction in biliary obstruction, stent patency, and reduced mortality and morbidity.

    3.3

    The professional experts and the committee considered the key safety outcomes to be: biliary tract perforation, biliary track infection and inflammation, and pain.

    3.4

    One patient organisation submission was received. Patient commentary was sought but none was received.

    Committee comments

    3.5

    The committee was informed that this procedure can be done by clinicians who are experienced in endoscopic retrograde cholangiopancreatography.

    3.6

    There is more than 1 device available for this procedure.

    3.7

    The results of some studies suggest that this procedure improves overall survival and reduces mortality, but the reason for this is not well understood. There is also no data on quality of life using a conventional tool.

    3.8

    The effect of this procedure in relieving biliary obstruction may enable chemotherapy to be offered to people who otherwise would not be able to have it. But, its effect on stent patency is uncertain.

    Tom Clutton-Brock
    Chair, interventional procedures advisory committee
    May 2024

    ISBN: