Improving patient and user safety during endoscopic investigation of the pancreatic and biliary ducts

Endoscopic investigation of the main pancreatic duct and biliary ducts is called endoscopic retrograde cholangiopancreatography (ERCP), and carries a risk of pancreatitis for the patient. During ERCP, a metal guidewire is inserted into the pancreatobiliary duct from a side-viewing large endoscope within the duodenum. To verify correct placement of the ERCP guidewire, an injection of radiopaque dye is required for fluoroscopic imaging, which exposes the patient and clinical team to x-ray radiation. A safer and more effective means to access the pancreatobiliary system can use direct optical imaging, although the endoscope diameter and stiffness will be significantly larger than a guidewire's. To quantify this invasiveness before human testing, a synthetic force-sensing pancreas was fabricated and attached to an ERCP training model. The invasiveness of a new, 1.7-mm diameter, steerable scanning fiber endoscope (SFE) was compared to the standard ERCP guidewire of 0.89-mm (0.035") diameter that is not steerable. Although twice as large and significantly stiffer than the ERCP guidewire, the SFE generated lower or significantly less average force during insertion at all 4 sensor locations (P<0.05) within the main pancreatic duct. Therefore, the addition of steering and forward visualization at the tip of the endoscope reduced the invasiveness of the in vitro ERCP procedure. Since fluoroscopy is not required, risks associated with dye injection and x-ray exposure can be eliminated when using direct optical visualization. Finally, the SFE provides wide-field high resolution imaging for image-guided interventions, laser-based fluorescence biomarker imaging, and spot spectral analysis for future optical biopsy.