Biliary endoscopy: Emerging technologies• Improve diagnosis of indeterminate biliary strictures? • Improve stenting for malignancy? • Improve treatment of benign biliary strictures
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Robert H. Hawes, M.D.Center for Interventional Endoscopy at AdventHealth Orlando
Medical Director,Institute for Minimally Invasive Therapy
Professor of Internal Medicine,University of Central Florida College of Medicine
University of California, Irvine12th Annual Gastroenterology & Hepatology Symposium
Disney’s Californian Hotel & SpaAnaheim, CA
February 28-29, 2020
Biliary endoscopy: Emerging technologies
Disclosures
• Olympus• Consultant
History of ERCP
• Diagnostic test (1968 – 2002)
• Therapeutic
• Sphincterotomy: 1974 (Kawai & Classen)
• Cholangioscopy: 1978 (Nakajima)
• Stent: 1979 (Soehendra)
• Plastic metal
Kawai – GIE 1974;20(4):148-51Classen – Dtsch Med Wochenschr 1974;99(11):496-7Nakajima – Gastrointest Endosc 1978;24(4):141-45Soehendra – Dtsch Med Wochenschr 1979;104(6):206-7
ERCP is 52 years old. The last major innovation was 41 years ago
ERCP for biliary disease
• Stones
• Cancer
• Benign strictures
• Inflammatory - PSC
• Post operative
ERCP for bile duct stones
• Sphincterotomy/balloon dilation Balloon/basket: 80% success
• Difficult bile duct stones
• Mechanical lithotripsy
• Large balloon dilation 90% success (index ERCP)
• SOC + EHL/Laser
ERCP for malignant biliary obstruction• Diagnosis
• Brush
• Bile 60-70%
• Blind biopsy
• SOC + targeted biopsy – 90%
• Therapy• Palliative
• Stent: plastic metal
• Therapy• Photodynamic therapy
• RFA
ERCP for benign biliary strictures
• PSC : balloon dilation
• Post-operative : Multiple plastic metal
How can we improve biliary endoscopy?
• Improve management of bile duct stones?
• Improve diagnosis of indeterminate biliary strictures?
• Improve stenting for malignancy?
• Improve treatment of benign biliary strictures
• Alternatives to ERCP?
How can we improve management of bile duct stones?
• Improve success rate for index ERCP
• Cannulation
• stone extraction
• Improve safety
• Pancreatitis
• Cholangitis
• Perforation
• Reduce time
• Reduce cost
• Reduce technical complexity
Accomplishing these goals is dependenton training and developing algorithms,
not on new technology
How can we improve diagnosis of indeterminate biliary strictures?
• Improve blind sampling
• Improve tissue acquisition in targeted biopsies
• EUS guided tissue acquisition
Flourescence in situ hybridization (FISH) for the diagnosis of cholangiocarcinoma (CCA) in PSC: a systematic review and meta-
analysis
• Pooled data for CCA in PSC• 8 studies/828 patients
• Sens: 68% (95% CI, 61%-74%
• Spec: 70% (95% CI, 66%- 73%
• Pooled data for FISH polysomy• 6 studies/690 patients
• Sens: 51% (95% CI, 43% - 59%)
• Spec: 93% (95% CI, 91%-95%)
Navaneethan U et al. Gastrointest Endosc 2014;79(6):943-950
Detection of polysomy does not meanPatients will develop cancer
How good is EUS FNA currently?
22G 22G 25G 25Gp-
valueNo Suction Suction No Suction Suction
(n=88) (n=88) (n=88) (n=88)
Diagnostic cell block 71 (80.7) 63 (71.6) 56 (65.9) 67 (73.6) 0.177
ROSE – Diagnostic accuracy: % (95% CI) 99 (94-100) 93 (86-98)) 99 (94-100) 99 (94-100) 0.06
Bang et al. UEGW, 2016
• 352 patients
• Suction vs no suction
• 22 vs 25 gauge needle
• Standard bevel
Overall diagnostic accuracy: 96.6%
Bang et al. Clin Gastroenterol Hepatol 2018;16(11):1820-1828
ProCoreCook Shark-Core
Medtronic
EasyShot IIIOlympus
AcquireBSC
New generation FNB needles
Franseen FNB vs. Standard FNA
FNB FNA p-value(n=46) (n=46)
ROSE - Diagnostic adequacy: n (%) 46 (100) 44 (95.7) 0.495
ROSE - Total no. of passes for diagnostic adequacy: Median (IQR) 1 (1-1) 1 (1-1) 0.929
Specimen bloodiness: n (%) Mild 12 (26.1) 16 (34.8) 0.736Moderate 29 (63.0) 26 (56.5)
Severe 5 (10.9) 4 (8.7)
Cell block - Diagnostic adequacy: n (%) 45 (97.8) 38 (82.6) 0.030
Cell block - Diagnostic accuracy: n (%) 43 (93.5) 37 (80.4) 0.063
• Randomized trial• n=46 with solid pancreatic mass lesions• FNA and FNB performed in all patients
Bang et al. Gut 2018;67(12):2081-2084
Franseen FNB vs. Standard FNA
FNB FNA p-value
Median total tissue area, IQR (mm2): 6.1 (2.2-9.9) 0.28 (0.05-0.93) < 0.0001
Median total tumor area, IQR (mm2): 0.68 (0.23-2.8) 0.099 (0.004-0.3) < 0.0001
Desmoplastic fibrosis present: n (%) 33 (84.6) 13 (33.3) < 0.0001
Median area of desmoplastic fibrosis, IQR (mm2): 3.9 (0.5-8.2) 0 (0-0.11) < 0.0001
Architecture retained: n (%) 43 (93.5) 9 (19.6) < 0.0001
Suitable for immunohistochemistry studies: n (%) 41 (100) 28 (68.3) < 0.0001
Bang et al. Gut 2018;67(12):2081-2084
How can we improve stenting for malignancy?
• Drug eluding stents?
• Delivery of PDT with stents?
• RFA?
• EUS guided biliary drainage?
Efficacy of a metal stent with chemo eluding membrane (MSCPM) vs covered metal stent (CMS) for malignant biliary
obstruction
• Prospective comparative study
• Paclitaxel-incorporated membrane
• 106 patients: MSCPM – 60, CMS - 46
Endpoint P valueStent patency NS
Survival NS
AE NS
Jang SI et al. Dig Dis Sci 2013;58(3):865-71
Combining photo-sensitizer with metal stent for PDT treatment
• Polymeric photo-sensitizer (pullulan acetate-conjugated pheophorbide) incorporated into a metal stent
• In bench top model – PDT-stent sustained photodynamic activities for at least 2 mo
• After light exposure, the PDT-stent successfully generated cytotoxic singlet oxygen in the surrounding tissues
• Demonstrated apoptotic degradation of tumor cells in tumor mouse models
• Endoscopic biliary in-stent PDT treatments in mini pigs suggested efficacy of PDT-stent in cholangiocarcinoma
• Has potential for combined therapy in cholangiocarcinomaBae BC et al. Biomaterials 2014;35(30):8487-95
Can RFA improve management of malignant biliary obstruction?
• Prospective database, retrospective review
• 64 patients with malignant biliary obstruction
• Metal stent + RFA vs Metal stent alone
• Patients matched for age, diagnosis, performance status, palliative chemo
• Technical success 100% in both groups
• Multivariable Cox proportional regression analysis showed RFA to be an
independe3nt predictor of survival [HR 0.29 (0.11-0.76), p = 0.012
Sharaiha RZ et al. Dig Dis Sci 2014;59(12):3099-102
How can we improve biliary endoscopy?
• Improve management of bile duct stones?
• Improve diagnosis of indeterminate biliary strictures?
• Improve stenting for malignancy?
• Improve treatment of benign biliary strictures
• Alternatives to ERCP?
RT of EUS-guided biliary drainage vs. PTC in failed ERCP
Lee TH et al. Clin Gastroenterol Hepatol 2016;14(7):1011-19
Variable EGBD(n=34)
PTBD(n=32) P value
Technical success,% 94.1 96.9 0.008(NI margin 15%)
Functional success, % 87.5 87.1 0.4
Adverse events, % 8.8 31.2 0.02
Re-interventions, % 8 17 0.01
Median Length of Stay 6 (3-14) 12 (4-24) 0.001
RT comparing EUS and ERCP for primary biliary decompression in pancreatic cancer
ERCP EUS Risk ratioP
(n=34) (n=33) (95% CI)
Adverse events 5 (14.7) 7 (21.2)0.69 (0.24 -
1.97)0.487
Moderate severity: n (%) 2 (5.9%) 2 (6%) 0.97 (0.15-6.49) 0.999-
Technical success: n (%) 32 (94.1) 30 (90.9)1.04 (0.90 -
1.19)0.673
Stent dysfunction requiring reintervention: n (%)
1 (2.9) 1 (3.0)0.97 (0.06 -
14.9)0.999
Total bilirubin < 50% baseline at 2 week post-procedure: n (%)
31 (91.2) 32 (97.0)0.94 (0.83 -
1.06)0.614
Surgical resection : n (%) 5 (14.7) 5 (15.2)0.97 (0.31 –
3.04)0.999
JY Bang et al. Gastrointest Endosc 2018;88(1):9-17
Take home points• ERCP and now EUS form the basis for biliary endoscopy
• The indications for biliary endoscopy have not changed over the
last 50 years
• EUS (tissue acquisition/interventions), metal stents and single
operator cholangioscopy represent the most impactful
technologies influencing the practice of biliary endoscopy
• Optimal utilization of existing technologies rather than looking for
major new technologies should occupy the time of a young biliary
endoscopist
AdventHealth Orlando
ShyamVaradarajulu
MuhammadHasan
UdhayNavaneethan
Ji YoungBang
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