Initial results from a novel video cholangiospancreatocope: an international multicenter study

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 Seventy-seven 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). Nine 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. Post-procedural 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 cost-effectiveness and environmental impact.

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Journal
Endoscopy International Open
Published
2026-09-25
DOI
https://doi.org/10.1055/a-2965-6616
Primary Topic
Gallbladder and Bile Duct Disorders
Type
article
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article

Initial results from a novel video cholangiospancreatocope: an international multicenter study

Rogier P. Voermans, David M. de Jong, Mark Ellrichmann, Cecilia Binda et al.
Endoscopy International Open
Gallbladder and Bile Duct Disorders
article

Initial results from a novel video cholangiospancreatocope: an international multicenter study

Rogier P. Voermans, David M. de Jong, Mark Ellrichmann, Cecilia Binda, Heng Chi, Akin Inderson, A. Anderloni, Michael Praktiknjo, Aurelio Mauro, Jörn Arne Meier, Jan Werner Poley, Carlo Fabbri, Pieter Jan F. de Jonge, George J.M. Webster, Willem J. Lammers, Alessandro Repici, Marco Spadaccini, Marco J. Bruno
article en

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 Seventy-seven 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). Nine 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. Post-procedural 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 cost-effectiveness and environmental impact.

Endoscopy International Open
University College London Hospitals NHS Foundation Trust (GB), Dutch Cancer Society (NL), Leiden University Medical Center (NL), Maastricht University Medical Centre (NL), Erasmus MC (NL), University Hospital Münster (DE), Azienda Unità Sanitaria Locale Della Romagna (IT), Pius Hospital Oldenburg (DE), Cancer Genomics Centre (NL), Azienda-Unita' Sanitaria Locale Di Cesena (IT), Policlinico San Matteo Fondazione (IT), Amsterdam University Medical Centers (NL), Fondazione Humanitas per la Ricerca (IT), IRCCS Humanitas Research Hospital (IT), University College London (GB)
Openalex Percentile: Top 12%
Gallbladder and Bile Duct Disorders
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