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Pancreaticobiliary diseases

EDGE procedure can treat side-effects of bypass

The Axios fully covered, braided nitinol metal stent covered with silicone
Since April 2014, five gastric bypass patients with gallstones or obstructed bile ducts have been successfully treated with EDGE without experiencing weight gain

Although gastric bypass surgery has become an increasingly popular, some gastric bypass patients struggle with side effects from the procedure, which are difficult to treat due to the patients' surgically-altered digestive tract. In order to more effectively treat these conditions, NewYork-Presbyterian/Weill Cornell Medical Center has developed the EUS-Directed Transgastric ERCP (EDGE), the first minimally invasive procedure to treat pancreaticobiliary diseases in gastric bypass patients.      

"With the EDGE procedure, patients with gallstones and other causes of bile duct obstruction can usually be treated without the need for open surgery, which improves recovery time and greatly increases their comfort," said Dr Michel Kahaleh, chief of endoscopy in the division of gastroenterology and hepatology at NewYork-Presbyterian/Weill Cornell Medical Center and a professor of medicine at Weill Cornell Medical College, who developed the EDGE procedure. "We're proud to be the first hospital to successfully treat gastric bypass patients using this technique."

Dr Michel Kahaleh

Due to the rapid weight loss caused by gastric bypass surgery, gallstones and bile duct obstructions are common side effects and approximately 50 percent of patients who undergo the most common gastric bypass procedure develop gallstones and 25 percent may have their gallbladder removed.

Kahaleh developed EDGE based on his experience with the Axios, a lumen apposing metal stent, which is used to treat conditions such as pancreatic pseudocysts and bile duct obstructions.

The Axios is a fully covered, braided nitinol metal stent covered with silicone. The design of the stent includes 2 large end flanges measuring ≤24mm in diameter, creating tissue apposition in the saddle of the stent. This allows for endoscopic creation of a conduit or fistula between any two lumens into which the stent is deployed. The fully covered design serves to prevent leakage. Also the large lumenal diameter of the stent (≤15mm) permits for subsequent passage of a therapeutic endoscope. The stent is deployed over a catheter-based delivery system via endoscopic, sonographic, or fluoroscopic guidance.

The Axios stent devevloped by XLUMENA

Using Axios, he connects the accessible pouch to the excluded stomach. While the stent is in place, a specialised endoscope can extract the gallstone and drain the pancreas or the bile duct internally without using surgery.

During that process the bypass is temporarily rendered ineffective. Once the lumen apposing metal stent is removed and the pouch closed a few weeks later, the bypass efficiency is restored. Since April 2014, five gastric bypass patients with gallstones or obstructed bile ducts have been successfully treated with EDGE without experiencing weight gain. The total procedure takes around 90 minutes.

"When surgeons perform gastric bypass, they alter the anatomy to ensure that patients lose weight," said Kahaleh. "But the reconfigured stomach and intestines makes it difficult to access the bile duct and gallbladder through minimally invasive procedures."

The team recently published a paper in the journal Gastroenterology describing the EDGE procedure. The paper can be accessed here

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