PMID- 35597763
OWN - NLM
STAT- MEDLINE
DCOM- 20220830
LR  - 20221227
IS  - 1878-3562 (Electronic)
IS  - 1590-8658 (Linking)
VI  - 54
IP  - 9
DP  - 2022 Sep
TI  - Digital single-operator cholangioscopy in diagnostic and therapeutic 
      bilio-pancreatic diseases: A prospective, multicenter study.
PG  - 1243-1249
LID - S1590-8658(22)00465-0 [pii]
LID - 10.1016/j.dld.2022.04.019 [doi]
AB  - 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.
CI  - Copyright (c) 2022. Published by Elsevier Ltd.
FAU - Fugazza, Alessandro
AU  - Fugazza A
AD  - Division of Gastroenterology and Digestive Endoscopy, Department of 
      Gastroenterology, IRCCS - Humanitas Research Hospital, Via Manzoni 56, Rozzano, 
      Milan 20089, Italy.
FAU - Gabbiadini, Roberto
AU  - Gabbiadini R
AD  - Division of Gastroenterology and Digestive Endoscopy, Department of 
      Gastroenterology, IRCCS - Humanitas Research Hospital, Via Manzoni 56, Rozzano, 
      Milan 20089, Italy.
FAU - Tringali, Andrea
AU  - Tringali A
AD  - Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli 
      IRCCS, Universita Cattolica del Sacro Cuore, Centre for Endoscopic research 
      Therapeutics and training (CERTT), Roma, Italy.
FAU - De Angelis, Claudio Giovanni
AU  - De Angelis CG
AD  - Gastroenterology and Digestive Endoscopy Unit, AOU Citta Della Salute e Della 
      Scienza, University of Turin, Turin 10126, Italy.
FAU - Mosca, Piergiorgio
AU  - Mosca P
AD  - SOD Malattie Apparato Digerente, Endoscopia Digestiva, Malattie Infiammatorie 
      Croniche Intestinali, Ospedali Riuniti, Ancona, Italy.
FAU - Maurano, Attilio
AU  - Maurano A
AD  - Digestive Endoscopy Unit, AOU San Giovanni di Dio e Ruggi d'Aragona, Polo 
      G.Fucito Hospital, Mercato San Severino, Italy.
FAU - Di Mitri, Roberto
AU  - Di Mitri R
AD  - Gastroenterology and Endoscopy Unit, ARNAS Civico - Di Cristina - Benfratelli 
      Hospital, Palermo, Italy.
FAU - Manno, Mauro
AU  - Manno M
AD  - Gastroenterology and Digestive Endoscopy Unit, Azienda USL Modena, Carpi, Italy.
FAU - Mariani, Alberto
AU  - Mariani A
AD  - 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.
FAU - Cereatti, Fabrizio
AU  - Cereatti F
AD  - Gastroenterology and Digestive Endoscopy Unit, Cremona Hospital, Cremona, Italy.
FAU - Bertani, Helga
AU  - Bertani H
AD  - Gastroenterology and Digestive Endoscopy Unit, Azienda Ospedaliero Universitaria 
      di Modena, Modena 41126, Italy.
FAU - Sferrazza, Sandro
AU  - Sferrazza S
AD  - Gastroenterology and Endoscopy Unit, Santa Chiara Hospital, Trento, Italy.
FAU - Donato, Giulio
AU  - Donato G
AD  - Gastroenterology Unit, Department of Oncological and Specialty Medicine, Azienda 
      Ospedaliero-Universitaria Maggiore della Carita, Novara, Italy.
FAU - Tarantino, Ilaria
AU  - Tarantino I
AD  - Endoscopy Service, Department of Diagnostic and Therapeutic Services, ISMETT, 
      Palermo, Italy.
FAU - Cugia, Luigi
AU  - Cugia L
AD  - Division of Gastroenterology and Digestive Endoscopy, Department of Emergency, 
      Azienda Ospedaliero Universitaria Sassari, Sassari, Italy.
FAU - Aragona, Giovanni
AU  - Aragona G
AD  - Gastroenterology and Hepatology Unit, Ospedale Civile, AUSL, Piacenza, Italy.
FAU - Cantu, Paolo
AU  - Cantu P
AD  - Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale 
      Maggiore Policlinico, Milan, Italy.
FAU - Mazzocchi, Alessandro
AU  - Mazzocchi A
AD  - Gastroenterology Endoscopy Unit, San Giovanni battista Hospital, Azienda Usl 
      Umbria2, Foligno, Italy.
FAU - Canfora, Maria Laura
AU  - Canfora ML
AD  - Endoscopy Unit, AOU Cagliari, Cagliari, Italy.
FAU - Venezia, Ludovica
AU  - Venezia L
AD  - Gastroenterology and Digestive Endoscopy Unit, AOU Citta Della Salute e Della 
      Scienza, University of Turin, Turin 10126, Italy.
FAU - Bendia, Emanuele
AU  - Bendia E
AD  - SOD Malattie Apparato Digerente, Endoscopia Digestiva, Malattie Infiammatorie 
      Croniche Intestinali, Ospedali Riuniti, Ancona, Italy.
FAU - Maroni, Luca
AU  - Maroni L
AD  - Clinic of Gastroenterology and Hepatology, Universita Politecnica delle Marche, 
      Ancona 60126, Italy.
FAU - Zulli, Claudio
AU  - Zulli C
AD  - Digestive Endoscopy Unit, AOU San Giovanni di Dio e Ruggi d'Aragona, Polo 
      G.Fucito Hospital, Mercato San Severino, Italy.
FAU - Conte, Elisabetta
AU  - Conte E
AD  - Gastroenterology and Endoscopy Unit, ARNAS Civico - Di Cristina - Benfratelli 
      Hospital, Palermo, Italy.
FAU - Soriani, Paola
AU  - Soriani P
AD  - Gastroenterology and Digestive Endoscopy Unit, Azienda USL Modena, Carpi, Italy.
FAU - Ligresti, Dario
AU  - Ligresti D
AD  - Endoscopy Service, Department of Diagnostic and Therapeutic Services, ISMETT, 
      Palermo, Italy.
FAU - Vilardo, Emmanuelle
AU  - Vilardo E
AD  - Gastroenterology Endoscopy Unit, San Giovanni battista Hospital, Azienda Usl 
      Umbria2, Foligno, Italy.
FAU - Penagini, Roberto
AU  - Penagini R
AD  - Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale 
      Maggiore Policlinico, Milan, Italy.
FAU - Benedetti, Antonio
AU  - Benedetti A
AD  - Clinic of Gastroenterology and Hepatology, Universita Politecnica delle Marche, 
      Ancona 60126, Italy.
FAU - Arcidiacono, Paolo Giorgio
AU  - Arcidiacono PG
AD  - 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.
FAU - Khalaf, Kareem
AU  - Khalaf K
AD  - Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 
      4, 20072, Pieve Emanuele - Milan, Italy.
FAU - Troncone, Edoardo
AU  - Troncone E
AD  - Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy.
FAU - Costamagna, Guido
AU  - Costamagna G
AD  - Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli 
      IRCCS, Universita Cattolica del Sacro Cuore, Centre for Endoscopic research 
      Therapeutics and training (CERTT), Roma, Italy.
FAU - Repici, Alessandro
AU  - Repici A
AD  - Division of Gastroenterology and Digestive Endoscopy, Department of 
      Gastroenterology, IRCCS - Humanitas Research Hospital, Via Manzoni 56, Rozzano, 
      Milan 20089, Italy; Department of Biomedical Sciences, Humanitas University, Via 
      Rita Levi Montalcini 4, 20072, Pieve Emanuele - Milan, Italy.
FAU - Anderloni, Andrea
AU  - Anderloni A
AD  - Division of Gastroenterology and Digestive Endoscopy, Department of 
      Gastroenterology, IRCCS - Humanitas Research Hospital, Via Manzoni 56, Rozzano, 
      Milan 20089, Italy. Electronic address: andrea.anderloni@humanitas.it.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20220518
PL  - Netherlands
TA  - Dig Liver Dis
JT  - Digestive and liver disease : official journal of the Italian Society of 
      Gastroenterology and the Italian Association for the Study of the Liver
JID - 100958385
SB  - IM
MH  - *Biliary Tract Surgical Procedures
MH  - *Cholestasis
MH  - Constriction, Pathologic
MH  - Endoscopy, Digestive System
MH  - *Gallstones
MH  - Humans
MH  - *Pancreatic Diseases
MH  - Prospective Studies
OTO - NOTNLM
OT  - Difficult biliary stones
OT  - Indeterminate biliary stricture
OT  - Pancreatoscopy
OT  - Single operator cholangioscopy
COIS- Declaration of Competing Interest Alessandro Fugazza, Andrea Tringali, Alessandro 
      Repici and Andrea Anderloni are consultants for Boston Scientific. No others 
      discosures for the remaining authors.
EDAT- 2022/05/22 06:00
MHDA- 2022/08/31 06:00
CRDT- 2022/05/21 22:08
PHST- 2022/02/10 00:00 [received]
PHST- 2022/04/21 00:00 [revised]
PHST- 2022/04/26 00:00 [accepted]
PHST- 2022/05/22 06:00 [pubmed]
PHST- 2022/08/31 06:00 [medline]
PHST- 2022/05/21 22:08 [entrez]
AID - S1590-8658(22)00465-0 [pii]
AID - 10.1016/j.dld.2022.04.019 [doi]
PST - ppublish
SO  - Dig Liver Dis. 2022 Sep;54(9):1243-1249. doi: 10.1016/j.dld.2022.04.019. Epub 
      2022 May 18.