3 Committee considerations

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, reduced use of antidiabetic medication (in particular insulin) and weight loss.

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 and other metabolic disturbances

  • uses technology that is evolving

  • should be done by healthcare professionals with experience of advanced endoscopic technique and specific training in the duodenal mucosal resurfacing procedure

  • 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.

3.7

There are ongoing studies. The guidance will be considered for review when new key evidence is published.

ISBN: 978-1-4731-6113-9

  • National Institute for Health and Care Excellence (NICE)