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NICE consultation

NICE issues EndoBarrier consultation document

NICE plans to issue a guidance publication in July 2013

The UK’s National Institute for Clinical Excellence (NICE) issued a consultation document about safety and efficacy concerning the “Implantation of a duodenal-jejunal bypass sleeve for the management of obesity and/or type 2 diabetes”, in March 2013.

The document states that:

NICE’s Interventional Procedures Advisory Committee has considered the available evidence and has made provisional recommendations about implantation of a duodenal–jejunal bypass sleeve for the management of obesity.

The provisional recommendations include:

  • Current evidence on the safety and efficacy of implantation of a duodenal–jejunal bypass sleeve (DJBS) for managing obesity is limited in quality and quantity. Therefore, this procedure should only be used in the context of research. 
  • Clinicians should enter details about all patients undergoing implantation of a DJBS for managing obesity onto the National Bariatric Surgery Register and review local clinical outcomes.

The committee also considered the safety and efficacy of the device from the published literature, which included: implantation failure, gastrointestinal bleeding, device migration, obstruction, pharyngeal and oesophageal tears, seudopolyp formation and implant site inflammation, reduced absorption of dietary calcium and iron, as well as weight loss, glycated haemoglobin (HbA1c), total cholesterol, triglycerides and hypertension levels.

The committee said that they considered the quality of randomised controlled trials as “poor, with substantial loss of patients to follow-up and potential for bias.” However, they also noted that “patients with obesity who had this procedure experienced improvement in comorbidities including diabetic control, hypertension and lipid profile.”

NICE plans to issue a guidance publication in July 2013.

The consultation document can the viewed here.

Separately, the Association of British Clinical Diabetologists has announced that one of its research fellows, Dr Piya Sen-Gupta, is hoping to lead a multi-centre project to assess the impact of EndoBarrier on patients who remain poorly controlled and overweight despite GLP1 receptor agonist therapy.

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