IRCCS Humanitas Research Hospital & Humanitas University
Published January 2, 2023 | Version v1
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Dataset related to article "Digital single-operator cholangioscopy in diagnostic and therapeutic bilio-pancreatic diseases: A prospective, multicenter study "

Creators

  • 1. IRCCS Humanitas Research Hospital, via Manzoni 56, 20072 Rozzano (Mi) - Italy
  • 2. Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Centre for Endoscopic research Therapeutics and training (CERTT), Roma, Italy
  • 3. Gastroenterology and Digestive Endoscopy Unit, AOU Città Della Salute e Della Scienza, University of Turin, Turin 10126, Italy
  • 4. SOD Malattie Apparato Digerente, Endoscopia Digestiva, Malattie Infiammatorie Croniche Intestinali, Ospedali Riuniti, Ancona, Italy
  • 5. Digestive Endoscopy Unit, AOU San Giovanni di Dio e Ruggi d'Aragona, Polo G.Fucito Hospital, Mercato San Severino, Italy
  • 6. Gastroenterology and Endoscopy Unit, ARNAS Civico - Di Cristina - Benfratelli Hospital, Palermo, Italy
  • 7. Gastroenterology and Digestive Endoscopy Unit, Azienda USL Modena, Carpi, Italy
  • 8. Pancreato-Biliary Endoscopy and Endosonography Division, Pancreas Translational & Clinical Research Center, Vita-Salute San Raffaele University, Milan, Italy, IRCCS San Raffaele Scientific Institute, Milan, Italy
  • 9. Gastroenterology and Digestive Endoscopy Unit, Cremona Hospital, Cremona, Italy
  • 10. Gastroenterology and Digestive Endoscopy Unit, Azienda Ospedaliero Universitaria di Modena, Modena 41126, Italy
  • 11. Gastroenterology and Endoscopy Unit, Santa Chiara Hospital, Trento, Italy
  • 12. Gastroenterology Unit, Department of Oncological and Specialty Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara, Italy
  • 13. Endoscopy Service, Department of Diagnostic and Therapeutic Services, ISMETT, Palermo, Italy
  • 14. Division of Gastroenterology and Digestive Endoscopy, Department of Emergency, Azienda Ospedaliero Universitaria Sassari, Sassari, Italy
  • 15. Gastroenterology and Hepatology Unit, Ospedale Civile, AUSL, Piacenza, Italy
  • 16. Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
  • 17. Gastroenterology Endoscopy Unit, San Giovanni battista Hospital, Azienda Usl Umbria2, Foligno, Italy
  • 18. Endoscopy Unit, AOU Cagliari, Cagliari, Italy
  • 19. Clinic of Gastroenterology and Hepatology, Università Politecnica delle Marche, Ancona 60126, Italy
  • 20. Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele – Milan, Italy
  • 21. Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy
  • 22. IRCCS Humanitas Research Hospital, via Manzoni 56,20089 Rozzano (Mi) - Italy AND Humanitas University, Department of Biomedical Sciences, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele – Milan, Italy

Description

This record contains raw data related to article “Digital single-operator cholangioscopy in diagnostic and therapeutic bilio-pancreatic diseases: A prospective, multicenter study"

Background and aim: Digital single-operator cholangioscopy (D-SOC) is an endoscopic procedure that is increasingly used for the management of bilio-pancreatic diseases. We aimed to investigate the efficacy and safety of D-SOC for diagnostic and therapeutic indications.

Methods: This is a multicenter, prospective study(January 2016-June 2019) across eighteen tertiary centers. The primary outcome was procedural success of D-SOC. Secondary outcomes were: D-SOC visual assessment and diagnostic yield of SpyBite biopsy in cases of biliary strictures, stone clearance rate in cases of difficult biliary stones, rate of adverse events(AEs) for all indications.

Results: D-SOC was performed in 369 patients (201(54,5%) diagnostic and 168(45,5%)therapeutic). Overall, procedural success rate was achieved in 360(97,6%) patients. The sensitivity, specificity, PPV, NPV and accuracy in biliary strictures were: 88,5%, 77,3%, 83,3%, 84,1% and 83,6% for D-SOC visual impression; 80,2%, 92,6%, 95,1%, 72,5% and 84,7% for the SpyBite biopsy, respectively. For difficult biliary stones, complete duct clearance was obtained in 92,1% patients (82,1% in a single session). Overall, AEs occurred in 37(10%) cases.The grade of AEs was mild or moderate for all cases, except one which was fatal.

Conclusion: D-SOC is effective for diagnostic and therapeutic indications.Most of the AEs were minor and managed conservatively, even though a fatal event has happened that is not negligible and should be considered before using D-SOC.

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Additional details

Related works

Is supplement to
Journal article: 3559-7763 (ISSN)
Journal article: 10.1016/j.dld.2022.04.019 (DOI)