Felicia Turowski1, Ulrich Hügle2, Arno Dormann2, Matthias Bechtler3, Ralf Jakobs3, Uwe Gottschalk4, Ellen Nötzel5, Dirk Hartmann5, Albrecht Lorenz6, Frank Kolligs6, Wilfried Veltzke-Schlieker7, Andreas Adler7, Olaf Becker7, Bertram Wiedenmann7, Nataly Bürgel1, Hanno Tröger1, Michael Schumann1, Severin Daum1, Britta Siegmund1, Christian Bojarski8. 1. Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany. 2. Krankenhaus Holweide, Medizinische Klinik, Kliniken der Stadt Köln, 51058, Cologne, Germany. 3. Medizinische Klinik C, Klinikum Ludwigshafen, Bremser Str. 79, 67063, Ludwigshafen, Germany. 4. Klinik für Innere Medizin I, Dietrich Bonhoeffer Klinikum, Salvador-Allende-Str. 30, 17036, Neubrandenburg, Germany. 5. Innere Medizin I: Schwerpunkt Gastroenterologie, Sana Klinikum Lichtenberg, Fanningerstr. 32, 10365, Berlin, Germany. 6. Klinik für Allgemeine Innere Medizin und Gastroenterologie, Helios Klinikum Berlin-Buch, Schwanebecker Chaussee 50, 13125, Berlin, Germany. 7. Medizinische Klinik mit Schwerpunkt Gastroenterologie und Hepatologie, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany. 8. Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany. christian.bojarski@charite.de.
Abstract
BACKGROUND AND AIMS: The aim of the study was to evaluate the usefulness and diagnostic and therapeutic outcome of the single-operator cholangiopancreatoscopy (SOC) with SpyGlassDS™. METHODS: In a retrospective multicenter study between November 2015 and January 2017, SpyGlassDS™ procedures were analyzed in participating centers. Indications, accuracy of SOC-guided biopsies, management of large bile duct stones, and complications were analyzed. Follow-up was 4 months. RESULTS: Two hundred and six patients out of 250 examinations were evaluated. Indications were biliary stones (n = 132), bile duct stenosis (n = 93), stones and stenosis combined (n = 24), and bile duct leakage (n = 1). Of the 117 cases which were suspicious of malignancy, in 99 cases the lesion could be stratified into benign (n = 55) or malignant (n = 44) indicating a sensitivity of 95.5% and a specificity of 94.5% for the indication tumor. SOC-guided biopsies revealed a sensitivity of 57.7% with a specificity of 100%. In 107 examinations, biliary stones were visualized and could be completely removed in 91.1% with a need of three procedures (range 1-6) to achieve final stone clearance. In 75 cases, lithotripsy was performed and was successful in 71 cases (95%). Four out of 45 patients (8.9%) underwent cholecystectomy with surgical bile duct revision as a final therapy. Adverse Event (AE) occurred in 33/250 patients (13.2%) and Serious Adverse Event (SAE) occurred in 1/250 patients (0.4%). Cholangitis was 1% (n = 102) after peri-interventional administration of antibiotics and 12.8% (n = 148) without antibiotic prophylaxis (p < 0.001). CONCLUSIONS: SOC with SpyGlassDS™ became a new standard for the diagnosis of indefinite biliary lesions and therapy of large bile duct stones. The diagnostic yield of SOC-guided biopsies facilitated a definite diagnosis in most cases and should be improved by standardized biopsy protocols. SOC-guided interventions allowed removal of large biliary stones by SOC-guided lithotripsy. The complication rate of 13.2% can be considerably reduced by use of a single-shot antibiotic treatment.
BACKGROUND AND AIMS: The aim of the study was to evaluate the usefulness and diagnostic and therapeutic outcome of the single-operator cholangiopancreatoscopy (SOC) with SpyGlassDS™. METHODS: In a retrospective multicenter study between November 2015 and January 2017, SpyGlassDS™ procedures were analyzed in participating centers. Indications, accuracy of SOC-guided biopsies, management of large bile duct stones, and complications were analyzed. Follow-up was 4 months. RESULTS: Two hundred and six patients out of 250 examinations were evaluated. Indications were biliary stones (n = 132), bile duct stenosis (n = 93), stones and stenosis combined (n = 24), and bile duct leakage (n = 1). Of the 117 cases which were suspicious of malignancy, in 99 cases the lesion could be stratified into benign (n = 55) or malignant (n = 44) indicating a sensitivity of 95.5% and a specificity of 94.5% for the indication tumor. SOC-guided biopsies revealed a sensitivity of 57.7% with a specificity of 100%. In 107 examinations, biliary stones were visualized and could be completely removed in 91.1% with a need of three procedures (range 1-6) to achieve final stone clearance. In 75 cases, lithotripsy was performed and was successful in 71 cases (95%). Four out of 45 patients (8.9%) underwent cholecystectomy with surgical bile duct revision as a final therapy. Adverse Event (AE) occurred in 33/250 patients (13.2%) and Serious Adverse Event (SAE) occurred in 1/250 patients (0.4%). Cholangitis was 1% (n = 102) after peri-interventional administration of antibiotics and 12.8% (n = 148) without antibiotic prophylaxis (p < 0.001). CONCLUSIONS: SOC with SpyGlassDS™ became a new standard for the diagnosis of indefinite biliary lesions and therapy of large bile duct stones. The diagnostic yield of SOC-guided biopsies facilitated a definite diagnosis in most cases and should be improved by standardized biopsy protocols. SOC-guided interventions allowed removal of large biliary stones by SOC-guided lithotripsy. The complication rate of 13.2% can be considerably reduced by use of a single-shot antibiotic treatment.
Authors: Amrita Sethi; Yang K Chen; Gregory L Austin; William R Brown; Brian C Brauer; Norio N Fukami; Abdul H Khan; Raj J Shah Journal: Gastrointest Endosc Date: 2010-11-24 Impact factor: 9.427
Authors: Peter V Draganov; Shailendra Chauhan; Mihir S Wagh; Anand R Gupte; Tong Lin; Wei Hou; Chris E Forsmark Journal: Gastrointest Endosc Date: 2012-02 Impact factor: 9.427
Authors: Yang K Chen; Mansour A Parsi; Kenneth F Binmoeller; Robert H Hawes; Douglas K Pleskow; Adam Slivka; Oleh Haluszka; Bret T Petersen; Stuart Sherman; Jacques Devière; Søren Meisner; Peter D Stevens; Guido Costamagna; Thierry Ponchon; Joyce A Peetermans; Horst Neuhaus Journal: Gastrointest Endosc Date: 2011-07-18 Impact factor: 9.427