By Christine Phelan, The Sun, Lowell, Mass.
Jul. 7–BURLINGTON — Doctors at Lahey Clinic are investigating a new device that may prove a non-surgical alternative to gastric bypass and a route for resolving type 2 diabetes — a disease that plagues nearly one in 10 American adults and nearly 250 million people around the world.
The EndoBarrier Gastrointestinal Liner — a two-foot plastic sleeve with a nickel-titanium anchor at one end that adheres to the soft tissue in the duodenum — nestles within the first two feet of the small intestine, allowing food to pass through a portion of the tract without being absorbed.
The effect mimics gastric bypass — a procedure that reduces stomach size and surgically reroutes first few feet of the small intestine — but without going under the knife. It’s currently being tested in 40 gastric bypass patients at four U.S. medical centers, including Lahey, who are required to lose weight before surgery.
There are few options for the nearly 70 million American adults who are either obese or morbidly obese, defined as a BMI of 35 and 40, respectively. They’re often beyond making dietary changes, and exercise — given the physical limitations of their size — is often out of the question.
For many, it’s surgery or facing life with the debilitating effects of obesity — everything from heart disease to cancer, depression to diabetes. Obesity is considered the second leading cause of preventable death in the U.S., after smoking.
And while gastric bypass is increasingly
popular — one study found a six-fold increase in the surgeries between 1998 and 2002 — Lahey surgeon Dmitry Nepomnayshy said roughly one percent of obese people eventually choose it. About 200,000 Americans had the surgery in 2007.
“A lot of people are afraid, and rightfully so,” said Nepomnayshy, the chief investigator in the EndoBarrier trial.
“There’s pain and suffering associated with surgery, risk of complications, even though it’s the most effective treatment for obesity. But obesity is dragging down our health care system like a big anchor. Right now (other than surgery), all we can tell you is go out and exercise, eat right. This is another tool for treatment, another option.”
Inserted through the mouth while the patient is under general anesthesia, the EndoBarrier is nudged into place and then deployed into the intestine like an unraveled parachute. The procedure takes 30 minutes. Patients are kept on a liquid diet for a week, purees for another, finally progressing to normal meals thereafter.
“Percentage-wise, the device isn’t covering a big portion of the small intestine,” explained Nepomnayshy, “but the results are impressive and we think it’s because it’s the area — that first part — where the absorption of nutrients takes place.”
While there’s not complete scientific agreement on how the body processes food, most doctors agree that the first couple of feet of intestine are critical both for nutrient absorption and spurring hormonal shifts that stimulate the pancreas to produce insulin.
The FDA has approved the device for a 12-week period, and patients in the trial have lost between 11 and 26 pounds. The next stage, said spokesman Jonathan Hartmann from Lexington-based GI Dynamics, will be to test the device’s efficacy over three, six and 12 months. There are no plans, Hartmann added, to ever permanently implant the EndoBarrier.
Though the device requires further testing, Nepomnayshy called the device promising.
“Right now, obesity is one of the biggest health problems out there, and not just obesity itself but the diseases it causes — cancer, diabetes, joint pain,” he said. “People not choosing surgery still need help; we have to offer them something else. This is an example of something that’s down the road that may just help them.”
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