Subhas Banerjee Director of Endoscopy Associate Professor of Medicine Stanford University School of Medicine

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1 Subhas Banerjee Director of Endoscopy Associate Professor of Medicine Stanford University School of Medicine

2 Fluoroscopic imaging False negatives early lesions Indeterminate/equivocal findings False positives Operator interpretation Suboptimal information re extent of disease Tissue sampling less well directed

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4 Dual Operator Cholangioscopy Mother-daughter systems Single Operator Cholangioscopy SpyGlass TM Direct Per Oral Cholangoscopy

5 Nakajima M, et al. Am J Gastroenterol 1976;66:241 Rösch W, et al. Endoscopy 1976;8:172

6 Company Model Pentax FCP-9P Olympus CHF-BP30 Image Field Of View Tip Deflection Diameter (mm) Accessory Channel (mm) Length (cm) Fibreoptic 90 2 way Fibreoptic 90 2 way

7 Logistic issues: 2 endoscopists necessary 2 processors/systems necessary Need to reserve loaner cholangioscope, preschedule procedure Technical Issues: Fragility of endoscope Limited steering and tip deflection ability up down only Fibre-optic Limited suction and irrigation ability

8 Company Model Boston Scientific SpyGlass TM Legacy Image Field Of View Tip Deflection Diameter (mm) Accessory Channel (mm) Length (cm) Fibreoptic 70 4 way irrigation lumens (0.6 mm) 1 optical fibre lumen (0.9 mm) Optical fibre: 6,000 pixel bundle

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11 Digital Single Operator Systems: SpyGlass TM DS Direct Per Oral Cholangioscopy: Ultraslim Gastroscopes

12 Company Model Boston Scientific SpyGlass TM DS Image Field Of View Tip Deflection Diameter (mm) Accessory Channel (mm) Length (cm) Digital way

13 Diagnostic Indeterminate Biliary Stricture Targeted Biopsy Therapeutic Lithotripsy Complex Biliary Stones

14 Diagnostic Indeterminate Biliary Stricture Targeted Biopsy Therapeutic Lithotripsy Complex Biliary Stones Assessing extent of cholangiocarcinoma Assessing extent of ampullary neoplasms Assessing extent of IPMNs Evaluation of indeterminate filling defects Facilitating Confocal Endomicroscopy Evaluation of unexplained Hemobilia Selective Guidewire Advancement cystic duct, hilar stenosis etc Tumor ablation: APC, facilitating PDT Retrieval, proximally migrated stents Hemostasis

15 Contraindications Active Cholangitis Small bile duct diameter

16 Complication ERCP alone ERCP + Cholangioscopy Cholangitis 0.2% 1% Pancreatitis 1.3% 2.2% Perforation 0.3% 1%

17 Thosani N et al, Endoscopy 2016

18 % Positive Blood Cultures after ERCP/SOC 27.8% Following ERCP alone (transient bacteremia) 8.3% Sustained bacteremia 19.4% Following ERCP+SOC (sustained bacteremia) 5.6% Following SOC alone (sustained bacteremia) 13.9% Clinically significant infections requiring Abx 9.7% Thosani N et al, Endoscopy 2016

19 Review of studies studies 1556 patients 861 patients with malignancy Positive cytology: 358 patients Overall sensitivity: 41.6%±3.2 Burnett AS et al, J Surg Res 2013

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21 N=26 (17 malignant) Sensitivity % Specificity % NPV % Accuracy % Cytology Standard forceps Spyglass & Spybite Draganov PV, Gastrointest Endosc 2012

22 Study N Sensitivity Specificity PPV NPV Accuracy Ramchandani 2011 Dragonov 2012 Hartman 2012 Kalaitzakis* 2012 Manta % on ITT NR

23 Adequacy of biopsies for histology: 72-97% <4 biopsies: 64% samples adequate 4 biopsies: 90% samples adequate 6 biopsies: 100% samples adequate Kalaitzakis E et al 2012, Eur J Gastroenterol Hepatol

24 Difficult Stones Size Downstream Stricture Location Intrahepatic Cystic duct (Mirizzi syndrome) Bouveret s syndrome

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34 Author N Pancreatoscope EHL/LL Success Rate Howell DA 1997 Fishner DJ 2009 Maydeo A 2011 Alatawi A 2013 Attwell AR 2013 Attwell AR Fr baby scope EHL 83% 6 Spyglass EHL 50% 4 Spyglass LL 100% 5 Spyglass LL 80% 46 Baby scope (n=31) Spyglass (n=15) EHL+LL 68% 73% 28 Spyglass LL 79%

35 Digtial image, but could be improved Cost: disposable system Small working channel (1.2mm) Small biopsies: mini biopsy forceps Limited number of accessory devices

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37 Digital Imaging Superior optics Electronic Chromoendoscopy Cost savings: No need for separate platform Reusable Larger working Channel Effective tissue sampling Effective therapeutic intervention

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44 Complications (n=130) n % Failure 22 17% Bleeding 2 1.5% Cholangitis 2 1.5% Pain/Hypoxia/Bradyarrhythmia 3 2.3% Air embolism 1 0.8% Bile duct perforation 2 1.5% Farnik H et al, Endoscopy 2014

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46 High definition optics Electronic Chromo-endoscopy Easy advancement and manipulation Adequately sized working channel Development of additional accessories Cost issues: reusable low cost disposable Evolution of indications

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48 Thank You!