Initial Results from a Novel Video Cholangiopancreatoscope: An International Multicenter Study.

Abstract

Background Novel 8.9-Fr and 11-Fr digital cholangiopancreatoscopes (Scivita Medical) have recently become available in Europe, but data on technical performance and safety remain limited. We report initial real-world experience with the Scivita platform. Methods This international, multicenter, retrospective cohort study included consecutive patients undergoing digital single-operator cholangioscopy (dSOC) or pancreatoscopy (dSOP) between March and October 2025 at 10 European centers. The primary outcome was technical success, defined as achievement of the intended procedural goal. Secondary outcomes included intra- and post-procedural complications, classified using the AGREE classification. Results In total, 77 patients (54.5% female; median age 70 years [IQR: 60-76]) were included. In 68 patients, 78 dSOC procedures achieved an overall technical success rate of 91% (71/78): choledocholithiasis 87% (33/38), biliary strictures 96% (24/25), selective cannulation 100% (2/2), evaluation of intraductal margins 50% (1/2), and migrated stent removal 100% (1/1). In all, 9 patients underwent 11 dSOP procedures, with an overall technical success rate of 63.6% (7/11): stone clearance 66.7% (4/6), intraductal papillary mucinous neoplasm assessment 50% (1/2), bridging pancreatic duct disruption 0% (0/1). No intraprocedural complications occurred. Postprocedural complications followed six dSOC procedures: cholangitis in two, mild post-ERCP pancreatitis in two, and abdominal pain without a clear substrate in two. One patient developed mild pancreatitis after dSOP. Conclusion Scivita dSOC demonstrated high technical success and an excellent safety profile. Larger prospective studies are warranted to validate these findings and define the role of dSOC and dSOP of Scivita cholangiopancreatoscopy in clinical practice, while also taking into account cost-effectiveness and environmental impact.