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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 5 sources, which was discussed by the committee. The evidence included 1 randomised controlled trial, 2 prospective cohort studies (1 study with 2 publications) and 1 proof of concept study. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.

    3.2

    The professional experts and the committee considered the key efficacy outcomes to be: quality of life, improved blood sugar control and reduced use of antidiabetic medication, in particular insulin.

    3.3

    The professional experts and the committee considered the key safety outcomes to be: perforation, duodenal stenosis and gastrointestinal symptoms.

    3.4

    Patient commentary was sought but none was received.

    Committee comments

    3.5

    The committee was informed that this procedure:

    • is used in addition to dietary control and other lifestyle modifications

    • may reduce the need for insulin and other antidiabetic medications, as well as improving blood glucose control

    • uses technology that is evolving, which may affect its safety profile

    • uses advanced endoscopic technique, so clinicians need specialised training and experience to carry it out, including in using fluoroscopy and guidewires

    • could be done as a day-case procedure.

      3.6

      Registry data may be helpful in determining the safety and long-term efficacy of the procedure.

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

      ISBN: