Physicians at Piedmont Hospital are now using a new cholangioscopy technology to diagnose and treat conditions such as obstructions due to mass, strictures and stones within the biliary tract. The device, known as the SpyGlassTM Direct Visualization System, includes 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. This device also allows taking biopsies under direct visualization for accurate diagnosis.
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.
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.
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 suggest that the direct visualization provided by the SpyGlass System may offer tremendous advantages that until now have not been possible with traditional ERCP systems,” said Roshan Shrestha, M.D., therapeutic endoscopist and medical director of liver transplantation, Piedmont Hospital Transplant Services. “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.”