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The Endobarrier is an endoscopic device used internationally but not in the U.S. (see Figure 17, page
45), although the manufacturer is located near
Boston, MA. 46-48 The procedure entails placing an
endoluminal polymer sleeve of more than 30 cm,
anchored with a metallic stent in the duodenum
that allows food to bypass the duodeno-jejunal axis,
as in the DJB or GB. It is strictly a metabolic procedure for treatment of T2DM. It uses the known
foregut mechanism of bypassing the duodenojejunal axis, thus minimizing insulin resistance and
enhancing GLP- 1 secretion and controlling T2DM.
Clinical trials in the U.S. are ongoing. The main
concerns have been liver abscesses from the spikes
of the metallic stent anchored in the duodenum
and perforating it, as well as gastrointestinal bleeding. The device is being used internationally, with
T2DM resolution reported as 60 to 74 percent at
one to two years of follow-up. It remains to be seen
whether the Endobarrier will be a good device to
indicate whether surgical DJB will affect resolution
of T2DM in a nonobese patient, as gastric balloons
achieve similar results with fewer complications.
More operations, procedures, and devices for
bariatric metabolic surgery are available internationally than in the U.S. because other countries
have fewer regulatory and professional roadblocks to the use of new treatments. The plethora
of available procedures is accompanied by concerns regarding safety and documentation. These
innovations often lead to paradigm shifts in our
understanding of both the physiology of our
interventions and the disease process itself. Governmental oversight analogous to the FDA may
not exist in some countries; however, ethical standards exist in all countries, although they differ
from one another. For example, the Declaration of
Helsinki, now in its seventh revision, is the most
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