Doctors at Piedmont Hospital Help Pioneer New SpyGlass™ System

May Alter Diagnosis and Treatment of Patients with Liver,
Gallbladder and Bile Duct Conditions: First of its Kind in Atlanta

Local Man’s Health Scare Shows Value of New System that Provides Direct Visualization of
Patient’s Bile Ducts and May Reduce Need for Additional Testing and Repeat Procedures

When the doctor at his local hospital diagnosed Ira Crawford with bile duct cancer and said he was discharging him so he could spend his final days at home, the 82-year-old Griffin, Ga. man replied, “No, I’m going to discharge you.”

Crawford had witnessed the end stages of cancer before and knew he was not that sick. But, after 19 days in the hospital, Crawford knew something had to be done because his condition was getting worse and worse every day; his urine was black and his stool was gray. Bile duct cancer has an 80 to 90 percent mortality rate and the average patient survives six months.

Fortunately for Crawford, his regular doctor researched his condition and discovered that physicians at Piedmont Hospital were now using a new cholangioscopy technology to diagnose and treat conditions such as obstructions due to mass, strictures and stones within the biliary tract.

Using the new technology that is part of the SpyGlass™ Direct Visualization System, Roshan Shrestha, M.D., therapeutic endoscopist and medical director of liver transplantation, Piedmont Hospital Transplant Services, was able to use a miniature 6,000 pixel fiber optic probe that provides physicians with a direct view of a patient’s bile ducts, overcoming some of the visual challenges of conventional ERCP procedures. Dr. Shrestha was able to visualize the area in Ira Crawford’s liver and diagnose that it was a stone in his bile duct located deep inside the liver – a much better diagnosis than cancer.

As part of the traditional ERCP procedure undergone by almost 500,000 people in the United States annually, physicians use an endoscope – a long, flexible, lighted tube that is inserted through a patient’s mouth and directed through the stomach into the first part of the small intestine – in order to view the entrance to the biliary tract. At this point X-rays may be taken of the inside of the biliary tract. However, these X-rays are two-dimensional black and white images that often do not provide enough information to obtain a complete diagnosis. In Ira Crawford’s case, the doctor was not able to obtain an accurate image, which led to his diagnosis of cancer.

Data shows that up to 60 percent of ERCPs performed using brush cytology or fluoroscopic guidance fine needle aspiration 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. At times to make definitive diagnosis, patients undergo unnecessary surgery which carries higher morbidity and even mortality.

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, strictures or mass causing obstructions of the bile duct. 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. As a result, physicians are able to achieve an improved diagnosis for patients.

Piedmont Hospital is one of just 25 medical centers in the nation to be selected to use the Spyglass System in the second phase of clinical release for the device and is the first of its kind in metro Atlanta.

Direct visualization of the biliary system (cholangioscopy) has been possible for more than 30 years and its benefits are well documented in numerous published studies. However, the technology has not been widely adopted due to the cost and limitations of available devices. Boston Scientific designed the SpyGlass System to help therapeutic endoscopists overcome these hurdles and to make cholangioscopy feasible for a larger number of physicians.

Studies Demonstrate Clinical Benefits of SpyGlass System

A study evaluating the clinical utility and safety of the single-operator SpyGlass System for diagnostic and therapeutic endoscopic procedures in bile ducts was performed at the University of Colorado Health Sciences Center in Denver and the Beth Israel Deaconess Medical Center in Boston. Thirty-five patients underwent procedures with the SpyGlass System. Results were published in the May 2007 issue of Gastrointestinal Endoscopy, demonstrating that a single-operator system proved clinically feasible and provided adequate samples for histologic diagnosis and successfully guided stone therapy. The procedures were deemed safe and well tolerated.

In addition, results of a preclinical study described in the February 2007 issue of Gastrointestinal Endoscopy showed that success rates for access in all quadrants were significantly higher with the SpyGlass System than with conventional systems. In addition, higher success rates were attained using the SpyGlass System to access biopsy targets and to perform simulated biopsies. The SpyGlass System permitted access to 48 of 48 biopsy targets.

“These preliminary studies along with my personal experience on more than a dozen patients suggest that the direct visualization provided by the SpyGlass System offers tremendous advantages that until now have not been possible with traditional ERCP systems,” said Dr. Shrestha. “In addition, the SpyGlass System eliminates a significant clinical staffing requirement, provides the potential to improve the efficiency of the procedure, and will allow us to improve the quality of care to our patients.”

“I can’t recommend Dr. Shrestha highly enough. He saved my life,” said Crawford. “It’s great that he and his team got in there in time because I was in bad, bad shape.”
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