The procedure for diagnosing problems in the liver, gallbladder and bile ducts known as ERCP (endoscopic retrograde cholangiopancreatography) has been an important tool in locating stones and strictures in the biliary tract. Almost half a million people annually in the U.S. undergo the ERCP procedure.

 

However, it has long had limited visibility when it comes to clarifying issues in the narrower passageways of the bile and pancreatic ducts. Two-dimensional X-ray images cannot always provide enough information to obtain a complete diagnosis, which may lead to additional complicated procedures and exploratory surgery. That can take a huge toll on the patient.

 

Physicians at Saint Francis Hospital are now using a new cholangioscopy technology to diagnose and treat obstructions and stones in the biliary tract. The device, known as the SpyGlass™ Direct Visualization System, includes a miniature 6,000 pixel fiber optic probe that provides physicians a direct view of the bile duct. The SpyGlass System, developed by Boston Scientific Corporation, provides direct visual access into a patient's biliary duct to improve diagnosis by helping to identify stones and obstructions. A fiber optic probe attaches to a camera head and is inserted through a single-use catheter that can be steered in four directions. This is designed to allow the user to access and inspect all four quadrants of the examination and treatment area. SpyGlass represents a significant improvement over the two-dimensional black and white images produced by the traditional ERCP procedure. As a result, physicians are able to achieve an improved diagnosis for patients.

 

"It's an access platform that allows us to visualize what's in the bile duct with greater maneuverability," explained gastroenterologist Zack Taylor, MD.

 

In the conventional procedure, multiple angles can be scoped but in a black and white X-ray, endoscopists are looking at shadows which can confuse the nature of the strictures and the ability to determine if they are malignant or benign.

 

"For years we looked through these scopes, and they are fragile, only move in two directions, cannot biopsy and are notoriously easy to break, and very expensive," Taylor said. "We've known for years that if you can see up in there, it's more accurate."

 

If it's left in question after the standard ERCP, the next step had been to obtain a brushing with a catheter, but it has a relatively low yield, explained Taylor. In fact, he said, the sensitivity and accuracy of making a good diagnosis with such a biopsy is about 50 percent.

 

Data show that up to 30 percent of ERCPs performed using brush cytology or biopsy forceps for tissue diagnosis are inconclusive, potentially creating the need for additional testing or repeat procedures. Besides being inconvenient for patients having to return to the hospital, the procedure can take two or more hours and typically requires them not to eat or drink six to eight hours beforehand.

 

Basically, the SpyGlass platform is an adjunct to the ERCP. If there is a diagnostic dilemma, physicians like Taylor can utilize the SpyGlass probe and help a patient avoid potential exploratory surgery. This leads to better diagnosis of conditions like gallstones, suspected cancers, obstructions and cystic lesions. In fact, Taylor maintained, the accuracy of diagnosis with SpyGlass is about 90 percent. Not only can it help diagnosis in hard-to-see areas, the SpyScope can deliver electrohydraulic liphopripsy, blasting stones in the bile duct to pieces, which pass through the system, allowing the patient to forego surgery.

 

"We are the one and only hospital in Memphis with the SpyGlass system. It is an exciting advancement in diagnostic care," said Mike Lachina, MD, CMO. "SpyGlass underscores our commitment to provide high quality patient care using state-of-the-art medical technology."

 

It also improves the referral of surgery, added Taylor. The safety of SpyGlass is equivalent to that of ERCP and does not increase the risk. It does require a high level of training and experience, Taylor maintained, but can be done with one endoscopist.