A novel 8-Fr and 11-Fr digital cholangioscope (Scivita Medical) has recently become available in Europe, yet data on technical outcomes and safety are limited. With cholangioscopes from different brands entering the market, robust data are essential to guide device selection and clinical practice (1). In this study we report on real-world technical success and complication rates of  Scivita cholangioscopy (dSOC) and pancreatoscopy (dSOP).

This international, multicenter, retrospective cohort study included patients who underwent dSOC or dSOP between March and October 2025 at 10 European centers. The primary outcome was technical success per procedure, defined as achievement of the pre-specified procedural intent (for example, stone clearance, visual assessment with targeted biopsy, selective cannulation, or stent removal). Secondary outcomes included intra- and post-procedural complications, classified according to the AGREE classification (2). 

A total of 77 patients were included (42 female, 54.5%), with a median age of 70 years (IQR: 60–76).

In 68 patients, 78 dSOC procedures were performed. Overall technical success was 71/78 (91.0%). By indication, technical success rates were: stone clearance (33/38, 87%), indeterminate biliary strictures (IBDS) (24/25, 96%), selective cannulation (2/2, 100%), evaluation of intraductal margins after radiofrequency ablation for adenoma (1/1, 100%), assessment of intraductal papillary neoplasm of the bile duct (0/1, 0%), and migrated stent removal (1/1, 100%). Among IBDS cases, visual assessment suggested malignancy in 9 and benign disease in 15; biopsy was performed in 19, yielding 6 malignancies. No intraprocedural dSOC complications occurred. Post-procedural complications were reported in five procedures: cholangitis (n=2, AGREE II), mild post-ERCP pancreatitis (n=1, AGREE I), and abdominal pain without a clear substrate (n=2, AGREE I).

In nine patients, 11 dSOP procedures were performed. Overall technical success was 7/11 (63.6%). By indication, technical success rates included stone clearance (4/6, 66.7%), intraductal papillary mucinous neoplasm (1/2, 50%), and pancreatic duct disruption bridging (0/1, 0%). Two patients with incomplete stone clearance underwent a second dSOP, obtaining complete ductal clearance in both cases. One patient developed mild post-ERCP pancreatitis following failed cannulation for IPMN (AGREE II).

Scivita dSOC demonstrated high technical success rates and an excellent safety profile in a real-world, multicenter setting. In contrast, outcomes with dSOP were more variable and showed lower technical success rates. With the expanding availability of multiple cholangioscope platforms, systematic data evaluation is increasingly important to inform clinical use, optimize device choice, and refine patient selection. Larger prospective studies and European registries assessing the performance and clinical impact of dSOC and pSOCP are warranted to validate these findings and support evidence-based implementation.