Copyright 2012 ACG ACG 2012 Postgraduate Course Benign and Malignant Biliary Strictures: How to Evaluate and Manage g Michel Kahaleh, M.D. Chief Endoscopy Professor of Clinical Medicine Division of Gastroenterology and Hepatology ERCP Diagnostics – Forced to function as radiologists – Reading shadows Therapeutics – Trial and error for wire placement – “Shooting Shooting in the dark” dark “Clinical correlation required” October 2012 1 Copyright 2012 ACG ACG 2012 Postgraduate Course ERCP Clinical correlation – Brush cytology – Fluoroscopically-guided forceps biopsies – Intraductal FNA ERCP with Brush Cytology Patients N Sensitivity (%) Ponchon, 1995 233 35% 97% Lee, 1995 149 37% 100% Ornellas, 2006 50 40% 100% Jailwala, 1999 133 30% 100% Author/Yr Total 565 36% Specificity (%) 99% Fukuda - Gastrointestinal Endoscopy Volume 62, No. 3, 2005 October 2012 2 Copyright 2012 ACG ACG 2012 Postgraduate Course ERCP with Biopsy Author/year Patients N Ponchon, 1995 Schoefl, 1997 Jailwala, 2000 128 103 133 Total Sensitivity ((%)) 364 Specificity (%) ( ) 43% 65% 37% 48% 97% 100% 100% 99% Ponchon - Gastrointestinal Endoscopy December; 42(6):565-72 Cholangiopancreatoscopy – – – – Choledocholithiasis Biliary strictures Biliary stones Mucosal irregularity attributed to primary duct tumors – Villous tumors of the biliary epithelium Duodenoscope-Assisted Cholangiopancreatoscopy Gastrointest Endosc 1999;50:943-945 October 2012 3 Copyright 2012 ACG ACG 2012 Postgraduate Course Mother baby scope Two operators needed Two-way steering only Only one channel Scope fragility, high repair costs Limited tools/accessories Single Operator System Single-operator system Four-way F steering i capability bili Independent irrigation channels Diagnostic and therapeutic capabilities Single-use components for reliable, p consistent performance Improved therapeutic options Daily accessibility to technology October 2012 4 Copyright 2012 ACG ACG 2012 Postgraduate Course Single Operator System - Registry Gastrointest Endosc 2011;74:805-14. Single Operator System - Registry October 2012 5 Copyright 2012 ACG ACG 2012 Postgraduate Course Sites of interest were CBD 55% CHD and hilum 53% Main hepatic ducts 23% Intrahepatic 7% Ampulla 4% Gastrointest Endosc 2011;74:805-14. Indeterminate Biliary Strictures: Gastrointest Endosc 2011;74:805-14. October 2012 6 Copyright 2012 ACG ACG 2012 Postgraduate Course Criteria For SOC Stricture (location/grade) Ulceration Inflammation Growth Vascular pattern Quality Final diagnosis ? Peroral Cholangioscopy October 2012 7 Copyright 2012 ACG ACG 2012 Postgraduate Course FISH vs KRAS Kipp BR et al: J Mol Diagn 2010, 12:780–786 FISH vs KRAS Kipp BR et al: J Mol Diagn 2010, 12:780–786 October 2012 8 Copyright 2012 ACG ACG 2012 Postgraduate Course Indeterminate biliary strictures Normal reticular pattern Irregular large white vessels Meining: CGH 2008 October 2012 9 ACG 2012 Postgraduate Course October 2012 Copyright 2012 ACG 10 Copyright 2012 ACG ACG 2012 Postgraduate Course Suspicious Lesion Benign biliary strictures Benign biliary strictures: Chronic pancreatitis Biliary calculi Trauma Surgery Cholangiopathies October 2012 Stahl TJ : Ann Surg 1988 Smits ME: Br J Surg 1996 11 Copyright 2012 ACG ACG 2012 Postgraduate Course Background Plastic stents are frequently used, but associated with Occlusion (8-36%) Migration (1-23%) Multiple M l i l sessions/stents i / requirement i Deviere J : Ann Surg 1990 Farnbacher MJ: Am J Gastro 2000 Eickhoff A: Eur J Gastroenterol Hep 2001 Multiple Plastic Stents Success rate: 89% (40/45) with no recurrence at mean f/u 48.8 mos Costamagna G: GIE 2001 October 2012 12 Copyright 2012 ACG ACG 2012 Postgraduate Course Background - Uncovered self-expanding self expanding metal stents (SEMS) failed long-term therapy due to intraluminal mucosal hyperplasia and the inability to remove them - Typically yp y offered to patient p in whom surgery g y is not an option Deviere J: Gut 1994 Hausegger KA: Radiology 1994 Van Berkel AM: Endoscopy 2004 UVA Experience: GIE 2008, 67: 446-54 October 2012 Biliary sphincterotomy in all p patients CSEMS 10 mm x 40, 60 or 80 below cystic Multivariate analysis of factors predictive of success was performed f d (eg, ( patient i age, time in place, CSEMS length and etiology) 13 Copyright 2012 ACG ACG 2012 Postgraduate Course Results: GIE 2008 CSEMS in pplace median 4 months (1-28) ( ) Removal in 65 patients Follow-up post removal: median of 12 months (3-26) Stricture in the uncovered portion (3) Failure (3) uode a edema ede a preventing p eve t g removal e ova (2) ( ) Duodenal Success rate of 59/67 (88%) No predictor of success by logistic regression Failure ? October 2012 14 Copyright 2012 ACG ACG 2012 Postgraduate Course Choledochoscopy Several groups thus far studied the temporary placement with planned retrieval FCSEMSs Study Number of patients Etiology Stent type Success Cahen et al1 6 CP Hanaro 3–6 mo (predefined interval)/66% Mahajan et al2 44 CP, BDS, OLT, AIP, PSC Viabil Tringali et al3 17 CP Niti-S Unflared (7) Flared (10) 3.3 mo (3– 4.8mo)/83% Predefined removal at 6mo/43% (Unflared) 87% (Flared) Park, et al4 43 CP, BDS, OLT, postsurgical 2. FCMS with 4 anchoring fins; FCMS with both ends flared 6 mo- 91% with AF; 88% with flared ends 1. Cahen DL et al. Endoscopy 2008 Mahajan A et al. Gastrointest Endosc 2009;70(2):303–9 Tringali A et al. Gastrointest Endosc 2010 4. Park D et al. Gastrointest Endosc 2011 3. October 2012 15 Copyright 2012 ACG ACG 2012 Postgraduate Course Recurrent Stricture Metal Biliary Stents and Malignant Strictures Levy MJ : CHG 2004;2:273 October 2012 16 Copyright 2012 ACG ACG 2012 Postgraduate Course Metal Biliary Stents Wilson Cook: Zilver® Olympus: X-Suit NIR® Metal Biliary Stents Stainless steel or Nitinol Self expandable p from 8 Fr to 30 Fr October 2012 17 Copyright 2012 ACG ACG 2012 Postgraduate Course Fully Covered SEMS Conmed: Viabil® Fully Covered SEMS The WallFlex Biliaryy RX Stent,, introduced in 2008 & 2009 October 2012 18 ACG 2012 Postgraduate Course Copyright 2012 ACG Covered versus Uncovered October 2012 Better patency of covered SEMS ? Migration of covered SEMS ? Cholecystitis with covered SEMS ? Bridge to surgery ? -Short uncovered SEMS -Covered SEMS 19 Copyright 2012 ACG ACG 2012 Postgraduate Course Covered versus Uncovered Better patency Covered Identical risk of Cholecystitis Mild increased risk of Migration with Covered Partially Covered SEMS Regardless of Resectability ? Kahaleh et al: Endoscopy 2007 October 2012 20 Copyright 2012 ACG ACG 2012 Postgraduate Course Cost effective analysis: SEMS vs DoubleLayer vs Plastic ? Kahaleh et al: Endoscopy 2007 Cost effective analysis: CSEMS vs DoubleLayer vs Plastic ? SEMS placement 4384 $ DoubleLayer stent 4449 $ Polyethylene stent 4926 $ ------------------------------------------------- Readmission not taken into account Kahaleh et al: Endoscopy 2007 October 2012 21 Copyright 2012 ACG ACG 2012 Postgraduate Course Metal Stents for Benign strictures will be a future option Metal stents are efficacious and safe in Malignant biliary strictures. They provide longer periods of patency and better QOL SEMS dysfunction due to stent ingrowth seems to be lower with cSEMS. Thank you for your attention Questions: [email protected] October 2012 22
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