Endoscopic Retrograde Cholangiopancreatography (ERCP)

With a population of 1.25 billion, 70% of patients living in rural villages, and a physician-patient ratio of 1:1674, there are distinct challenges for patient access to appropriate care in the Indian healthcare system. In partnership with Boston Scientific Endoscopy, our objective was to analyze both the technical and systemic challenges associated with Endoscopic Retrograde Cholangiopancreatography (ERCP) in India to identify innovation targets that may increase patient access to ERCP in developing nations. Based on our insights from over 40 interviews with physicians in both India and the Johns Hopkins Medical Institutions, we have determined that a solution to facilitate the process of selective cannulation of the common bile duct during ERCP may have the highest clinical impact as it would reduce the training barriers for ERCP and increase the safety of the procedure. ERCP entails navigating an endoscope into the duodenum and gaining access into hepatobilitary tree to treat various diseases. At the start of the procedure the physician is tasked with threading a small guidewire (0.035” diameter) through a muscular sphincter to then enter the pancreaticobiliary tree in a process called “selective cannulation”. Once access has been established, physicians are able to perform therapies such as: retrieving obstructing gallstones, expanding tissue strictures, or placing a stent to relieve obstruction from malignancies. The most feared complication of this procedure is pancreatitis, which is a life-threatening condition that occurs in 5% of cases and is in part due to multiple failed cannulation attempts leading to tissue irritation. The high degree of technical skill and precision required for this procedure creates a steep learning curve, and it has been cited to require up to 400 cases for a physician to achieve an 80% success rate in selective cannulation. Our team is developing solutions to deskill the process of selective cannulation by addressing the two greatest challenges that our stakeholders have cited for performing ERCP: (1) visualization of the orientation of the common bile duct behind the papillary opening, and (2) increased control of the accessories (guidewire and sphincterotome) to decrease the risk of miscannulation into the pancreatic duct. Initial successes in ex-vivo experiments of our proof-of-concept prototypes have led us to pursue live porcine animal testing to validate their clinical efficacy. Results from the animal tests will further inform design decisions and future development iterations for this innovation target. We believe that our developments have the promise to positively impact therapeutic endoscopy by reducing training barriers for physicians and making safe ERCP more universally accessible for patients in the developing world.