Health Problem: The bile duct normally conveys bile from the gallbladder to the small intestine to facilitate the digestion of fats. However, gallstones can form in the gallbladder and be pushed into the bile duct to block the flow of bile. Gallstones can also cause pancreatitis since the bile duct joins the pancreatic duct before emptying into the small intestine. Other disorders that can occur are cancer and infections of the bile duct or adjoining pancreatic duct.

Technology Description: The SpyGlass system is used for taking biopsies or administering therapy through direct visual access of the bile ducts (cholangioscopy) or the biliary and pancreatic ducts (cholangiopancreatoscopy). The SpyGlass system consists of the SpyScope access and delivery catheter, which is attached to a standard duodenoscope and inserted through its working channel, the SpyGlass direct visualization probe, and the SpyBite biopsy forceps. Accurate navigation through the multiple branches of the biliary tract is possible because the SpyScope has dual controls that permit 4-way deflection of the 10Fr catheter, which has a 1.2 millimeter (mm) working channel and a separate 1.2 mm channel for visualization with the reusable SpyGlass probe. The SpyScope catheter also has 2 channels for irrigation and aspiration. The working channel is typically used for probes that enable collection of biopsy samples for diagnosis or for therapeutic procedures such as fragmentation of gallstones. Traditionally, this procedure requires 2 operators—the SpyGlass was designed as a single-operator device.

Controversy: Although conventional endoscopic systems for biliopancreatic diseases are less maneuverable than the SpyGlass system and may rely on fluoroscopic guidance rather than direct endoscopic visualization for navigation of the biliary tract, conventional endoscopic systems may still enable successful diagnosis or treatment of most patients.

Key Questions:

  • Does the SpyGlass system enable more accurate diagnosis of biliopancreatic disorders than conventional endoscopic systems?
  • Is the SpyGlass system more effective than conventional endoscopic systems for treatment of biliopancreatic disorders?
  • Is the SpyGlass system as safe as conventional endoscopic systems for diagnosis and treatment of biliopancreatic disorders?
  • Have definitive patient selection criteria been established for use of the SpyGlass system for biliopancreatic disorders?

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