Endoscopic management of bile duct cancers

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  • ENDOSCOPIC DIAGNOSIS AND MANAGEMENT OF BILE DUCT CANCERSJason Klapman, M.D.Associate Professor of MedicineDirector of EndoscopyGastrointestinal Tumor ProgramMoffitt Cancer Center

  • OutlinePre-Procedure EvaluationImaging studies Determine ResectabilityTissue Diagnosis ERCP-cyto/biopsies EUS with Fine Needle AspirationCholangioscopic directed biopsiesEndoscopic TreatmentStentingEndoscopic directed therapy

  • Bismuth ClassificationType 1 (Extrahepatic)25%Type II-IVKlatskins Tumors60-65%Intrahepatic CCA10-15%

  • Klatskins TumorDefinition- Perihilar tumors that involve the bifurcation of the hepatic ductRepresent 60-65% of all CCA5-year survival 15-30%Resectable in only 30%Palliation mainstay of treatment

  • Criteria For UnresectabilityMedical contraindications to surgeryN2 nodal disease or distant liver metastasesVascular invasionExtra-hepatic adjacent organ invasionPresence of disseminated diseaseLOCAL UNRESECTABILITY

  • Local UnresectabilityInvolvement of bilateral hepatic duct up to secondary radicles bilaterally, encasement/ occlusion or PV/ HA Determined by Imaging studiesCTscan, MRI/MRCP, ERCP and EUSSurgical Exploration

  • Klatskins Tumor

  • Work-upLabsImagingResectable?ERCPMRCP

  • Magnetic Resonance Cholangio-Pancreatography (MCRP)Non-invasiveDetailed imaging of biliary systemRoadmap for EndoscopistTargets therapyOptimizes TreatmentMinimizes complicationsCholangitis

  • ERCPMRCP

  • MRCPTARGETING THERAPYHintze et al GIE 2001Evaluated MRCP to aid in unilateral stent placement for Klatskins TumorsResolution of Bilirubin in 86%Cholangitis 2/35Freeman GIE 2003CT scan or MRCP to selectively target drainage using metallic stentsPalliation in 77% of patients

  • Traditional Work-upLabsImagingResectable?ERCPMRCPStentDX

  • Tissue Sampling by ERCPBrush CytologyForceps Biopsy

  • Brush Cytology in Malignant Biliary StricturesDe bellis et al, GIE 2002

    AuthorsYRPTsCa.TPSeSpePPVNPVFoutch et al913017633%100%100%58%Lee et al951491064037%100%100%39%Ponchon et al952041274535%97%96%44%Pugliese et al9594643554%100%100%50%Glasbrenner et al9978573256%90%84%43%Mansfield et al9743411742%100%100%8%Jailwala et al991331043130%100%100%28%Macken et al00106623557%100%100%62%Total83757824142%98%99%43%

  • ERCP-guided Biopsy of Malignant Biliary StricturesDe bellis et al, GIE 2002

    AuthorsYRPTsCa.TPSeSpePPVNPVKubota et al9241322681%100%100%75%Pugliese et al9452361953%100%100%48%Ponchon et al95128823543%97%97%41%Sugiyama et al9645312581%100%100%67%Schoefl et al97103583865%100%100%69%Jailwala et al991331044843%90%94%31%Total50234319156%97%97%51%

  • Combined Brush and Biopsy of Malignant Biliary stricturesDe bellis et al, GIE 2002

    AuthorsYRBrushBiopsyBrush and BiopsyPonchon et al9533%44%61%Pugliese et al9554%55%61%Schoefl et al9747%65%70%

  • EUS-guided FNAUseful in obtaining a diagnosis in pts with negative ERCP cytology and high index of suspicionFritscher-Ravens et al. GIE 20009/10 with Hilar lesions obtained a Tissue Diagnosis2 patients had LNs aspirated Eloubeidi et al. Clin Gastro and Hepatol 200425/28 pts underwent FNA18 CCA, 4 benign and 3 FNImpacted Pt management in 84%

  • EUS-guided FNA

  • EUS-guided FNA

  • Cholangioscopy with biopsiesSingle-operator system introduced in 2005Indeterminate biliary stricturesRamchandani et al. GIE 201136pts (22 malignant) underwent cholangioscopy with biopsiesAccuracy was 89% for differentiating malignant vs. non-malignant stricturesAccuracy in pts with previous inconclusive ERCP brushings or biopsies was 82%

  • Cholangioscopy with biopsiesDraganov et al. GIE 2012Compared conventional cytology brushings and biopsies and cholangioscopic biopsies on 26 patients (17 cancer)Cholangioscopic biopsies significantly higher accuracy (84.6% vs. 58% vs. 38.5 %)

  • Diagnostic algorithm for tissue diagnosis ERCP brushings/biopsy- if negativeEUS with FNA- if negativeERCP with cholangioscopic guided biopsies-if negative??DDx- benign vs. malignantConsider repeat ERCP with cholangioscopic biopsies if mass is seen and clinical suspicion high

  • Endoscopic PalliationStentingUnilateral vs. Bilateral?Plastic vs. Metallic?

  • Are two stents better than one to obtain resolution of jaundice? Technical issuesFeasibility of placing 2 stentsRisk of cholangitis of undrained biliary segment if unable to place 2 stentsMRCP useful to target drainageR hepatic duct 1cm L hepatic duct 3cmDrainage of 25% of liver resolves jaundiceL lobe-35%, R-lobe-55-60%, caudate lobe 10-15%

  • Unilateral vs. Bilateral StentingChang et al., GIE 1998Evaluated the outcomes of 98 patients with unresectable CCA who underwent unilateral or bilateral stentingRetrospective reviewPatients with bilateral drainage had a significant survival advantage 225 vs. 80 daysCholangitis 11% (32% in pts with un-drained segments)

  • Unilateral vs. Bilateral StentingDe Palma et al. GIE 2001 Compared unilateral vs. bilateral hepatic duct drainage157 patients randomly assigned prospectivelyUnilateral group had higher stent insertion success and less complicationsSuccessful drainage, survival comparable in both groupsConclusion:bilateral stenting not justified and may increase complications

  • Unilateral vs. Bilateral StentingDe Palma et al. GIE 2003 Evaluated Unilateral metal stent placement for hilar obstruction in 61patientsAll patients underwent MRCP pre-procedureStent insertion 59/61Successful biliary drainage in 59/61Cholangitis 5%Median stent patency of 169 days

  • Unilateral vs. Bilateral StentingNaitoh et al. J Gastroenterol Hep 2009 Retrospective series of 46 patients showed better outcomes with bilateral vs. unilateral stentingImproved stent patency bilateral group 488 vs. 210 days for unilateral group (p=.009)

  • Endoscopic PalliationPLASTIC vs. METAL?

  • Plastic Stents Metal StentsMedian Patency 3-5mosAverage diameter is 10Fr (3.3mm)Stent change q3mos. Median Patency 6-8mosSelf expandable up to 30Fr (10mm)Permanent

  • Plastic vs. Metal? Life ExpectancyQuality of LifeCostPhysician Expertise

    No Difference in Survival

  • ERCP ComplicationsImmediateCholangitisAntibiotics pre/post procedureSelective Opacification during ERCPPancreatitisBleedingLateStent Occlusion

  • New technologyCook Zilver635 systemUncovered metal stent deployment system that uses a 6fr deliver catheterSizes 6,8 and 10mm and 4,6 and 8cm lengthAdvantages over conventional SEMSLess need to dilate Hilar strictures as the introducer system is much smallerAllows simultaneous deployment of bilateral stents through the scopeThis allows easier access in the future to each side of the biliary system as they are side by side and not in the Y configuration

  • Zilver635 6F systemWaxman et al. GIE 201049 stents placed in 16 patientsTechnical success was 100%Side by Side deployment achieved in all 10 cases attemptedAdditional transpapillary stenting was performed for future accessConclusion- works great but would like longer lengths that may bridge papilla

  • Simultaneous deployment video

  • Tips and tricks for deploymentSpray Pam for lubrication Consider a small sphincterotomyAlthough different sizes exist, try and place largest diameter stent when possibleWhen stents unable to bridge papilla, consider deploying shorter 2nd stents within stents to allow for future access for re-intervention

  • Outline Pre-Procedure EvaluationImaging studies Determine ResectabilityTissue Diagnosis ERCP-cyto/biopsies EUS with Fine Needle AspirationCholangioscopic directed biopsiesEndoscopic TreatmentStentingEndoscopic directed therapy

  • Endoscopic ManagementEndoscopic-guided TherapyPhotodynamic Therapy

  • Photodynamic Therapy with

  • ERCP-guided PDTDumoulin et al. GIE 2003PDT and Metal stent as palliation for unresectable Klatskins tumor24 patients vs. 20 controlsMedian survival 9.9mos vs. 5.6mos Ortner et al. Gastro 2003Prospective randomized trial of PDT +stenting vs. stenting alone in Klatskins tumor20 patients vs. 19 controlsMedian Survival PDT group 493 vs.98 days

  • ERCP-guided PDTZoepf et al. Am J of Gastro 2005Randomized 32 pts to either PDT/stenting or stent alone for nonresectable CCAPhotosan-3 9/16 received 2 PDT sessions, 1 pt 3 sessionsMedian survival of PDT group was 21mos vs. 7mos.3/16 (PDT) developed cholangitis/infected bilomas

  • ERCP-guided RFASteel et al. GIE 201122 patients (16 pancreatic and 6 CCA)Deployment of RFA catheter successful in 21/22 SEMS placed in all patientsEnd point was safety at 30 and 90 daysEndobiliary RFA treatment appears safe Further studies are needed with longer duration

  • Summary

  • ConclusionCholangiocarcinoma still a challenge to diagnoseImproved technology including EUS/FNA and cholangioscopic directed biopsies have greatly improved yield in indeterminate stricturesBilateral stenting may be preferred when possible and is now made easier with the Zilver635 6f deployment system which allow simultaneous bilateral deployment Always use MRCP as a roadmap before ERCPNever place uncovered metal stents without a prior diagnosis

    Add referencesCholangitis occurs historically in 20-40%Unclear about added effects of brush and biopsy, pre/post stricture dilation, number of brushings obtained and location of strictureAtleast 3 specimensBottom line- Obtain tissue by using 2 methods to increase the yieldTissue rates higher for CCA than Pancreatic cancer25% of liver drained to normalize bilirubinLeft Liver drains 35%, R liver 55-60% and 10-15% drained by the caudate lobe. R hepatic duct is 1cm L hepatic duct 3cm in lengthNo diff of which