Endobarrier® Implantation

EndoBarrier implantation is a new endoscopic procedure for weight loss and diabetic control.

Please note, in accordance with TGA guidelines, the EndoBarrier device can be inserted for a maximum of 12 months.  After this time it must be removed.  Some of the positive effects on weight loss and diabetes may remain for some time after EndoBarrier removal.  There are trials underway looking at longer insertion times but at this stage one year is maximum.  If successful, it may be possible to re-implant the device after a waiting period of nine months or so post removal.

See How the EndoBarrier Works from Anthony Clough on Vimeo.

 

Description

The EndoBarrier Gastrointestinal Liner (GI Dynamics. Inc., Lexington, MA) was approved by the TGA of Australia in July 2011. The first devices in Australia were placed in late March at the Epworth Richmond hospital in Melbourne by Mr Harry Frydenberg and Mr Anthony Clough.

First placed worldwide in 2007, the EndoBarrier® is a device to induce weight loss and diabetes resolution which does not involve surgical cuts or surgical manipulation of the stomach or intestines. This device is a 60cm fluoropolymer sheath which is placed in the duodenum just beyond the stomach and stretches into the first part of the small bowel. The device lines the surface of the bowel preventing contact with the food and fluids ingested. Digestive enzymes coming from the duodenum are also prevented from mixing with the food over this distance.

The rationale for the procedure is based on the excellent weight loss and diabetes control observed after gastric bypass surgery in obese populations. In gastric bypass, food and fluids are separated from the duodenum and first part of the small bowel by anatomical re-arrangement. Amongst other things, this separation is thought to induce certain hormonal effects when food is ingested including increased levels of GLP-1* and PYY** hormones which can suppress hunger.¹

These hormones work on the hypothalamus in the brain as well as the pancreas to reduce appetite and stimulate the body to metabolise glucose better (and hence avoid or improve diabetes).


*Glucagon Like Peptide
**Peptide YY


¹De Jonge et al. EndoBarrier Gastrointestinal Liner rapidly improves diabetes parameters paralleled by increased postprandial GLP-1 and PYY levels in obese type 2 diabetic patients. ASN Abstracts 2011.

 

Possible Side Effects of the EndoBarrier

The following symptoms and adverse effects have been reported from EndoBarrier implantation in some patients:

  • Nausea
  • Vomiting
  • Upper abdominal pain
  • Bleeding
  • Device migration (although less nowadays)
  • Obstruction with vomiting

Nausea, discomfort and upper abdominal pain often settle after the first week or so. If these symptoms are severe enough to warrant device removal, the symptoms should then disappear after removal has occurred.

If the trials thus far, many devices have been removed before 12 months, usually for one of the reasons listed above. The risk of premature removal of the device before the 12 month period is around 20%.

Other complications such as bleeding from duodenum, liver abscess/infection and pancreatitis are occasionally seen.

 

Contraindications

The following are reasons why the device may not be suitable for a particular individual:

  • Gastric or duodenal ulcers
  • Previous bariatric surgery e.g. gastric band, sleeve gastrectomy etc.
  • Certain past abdominal surgeries or abdominal problems (such as generalised peritonitis or multiple bowel resections)
  • Age < 18 or > 65 years
  • Pregnancy or planning to become pregnant shortly
  • Requirement for blood thinning medications such as warfarin or clopidogrel or disorder of platelet or clotting function.  You cannot have an EndoBarrier if you take aspirin or other blood thinning medications
  • Known inflammatory bowel disease (e.g. Crohn’s disease)
  • Large hiatus hernia or para-oesophageal hernia present
  • Alcoholism or drug addiction
  • Liver cirrhosis

Perspective

EndoBarrier® implantation is still at the investigative stage but may be suitable in selected cases where conventional weight loss surgery is not possible or not desired. Anyone undertaking implantation of this device should be well informed as to the current worldwide experience and the self-limited nature of the intervention.

*Please note that as of late 2016 the TGA has withdrawn approval for Endobarrier implantation in Australia.  It is not clear when this decision may be reversed.  An alternative implantable device for those interested in an endoscopic solution is the Orbera balloon*

 

 

 

If you would like to discuss the EndoBarrier® in more detail or are considering trying this device please call (03) 9895 7215 to make an appointment with Mr Anthony Clough.