Title: EUS-GUIDED FNA: HOW DO I INCREASE THE YIELD? Session No.: 7

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1 Title: EUS-GUIDED FNA: HOW DO I INCREASE THE YIELD? Session No.: 7 Name: Tomas Hucl Institution: Department of Gastroenterology and Hepatology Institute of Clinical and Experimental Medicine Country: Czech Republic

2 EUS Endoscopic ultrasound powerfull tool in diagnosis and staging of endoluminal and extraluminal lesions Rosch T, Gastrointest Endosc 1991 With development of linear EUS, fine needle aspiration biopsy and other indications were added Vilmann P, Gastrointest Endosc 1992, Wiersema MJ, Gastroinest Endosc 1993

3 EUS-FNA Diagnostic accuracy of FNA up to 90% depending on site and lesion (higher for nodes, lower for pancreatic malignancies) Madhoun MF, Anedoscopy 2013 EUS-FNA is a safe procedure with complication rates between 1-2.5% Eloubeidi MA, Gastrointest Endosc 2006

4 FNA-YIELD FNA-yield already very high How do we get this yield and can we further improve it? Factors influencing the yield Experience (operator) Technique of biopsy Needles On site pathology

5 EXPERIENCE Learning curve for EUS-FNA, linear FNA proficiency first FNA in 57 patients by self-taught endosonographer, sensitivity for diagnosis of malignancy was 30, 40, 70, 90, 80%/quintiles Mertz H, Gastrointest Endosc 2004 FNA in 300 consecutive patients, number of passes decreased significantly with no difference in accuracy Recommendation Eloubeidi MA, Gastrointest Endosc 2005 ESGE: supervised procedures Polkowski M, Endoscopy 2012 ASGE: competency assessmet after 25 FNAs Eisen GM, Gastrointest Endosc 2008

6 LOCATION/DIFFICULTY Technical difficulty influences yield Technical difficulty depends strongly on location Transesophageal and transgastric FNA easier Transduodenal more difficult Acute angulation of tip Torsion Elevator use Needle type selection/location (19G, 25G, flexible 19G)

7 PUNCTURE TECHNIQUE Center of malignant mass necrotic Pancreatic cancer often fibrotic Repeated sampling along same trajectory increase bloodiness Fanning-aspirate across lesion in multiple trajectories (4x2, 4x4) from one margin to the other RCT with 54 patients, first pass diagnostic in 85.7% vs. 57.7% (p=0.02) Bang JY, Endoscopy 2013 " jabbing" (Chang KJ) and other techniques Lymph nodes not important Wallace MB GI Endoscopy 2011

8 SUCTION Increases quantity of material Specimen tends to be bloodier, diminishing quality RCT in lymph nodes, more blood, same diagnostic accuracy Wallace MB, Gastroinest Endosc 2001 RCT, pancreatic mass, higher yield without increase in bloodiness, higher sensitivity for malignancy Puri R, Scand J Gastroenterol 2009 RCT, diagnostic yield, bloodiness, accuracy, sensitivity better for suction Lee JK, Gastrointest Endosc 2013

9 STYLET Prevents hollow tip of needle from filling with esophageal, gastric or duodenal wall tissue before it enters the target organ 3 studies (1RCT); FNA in the same lesion with and without stylet, no improvement of diagnostic yield for malignancy, increased bloodiness of specimen Sahai AV, Endoscopy 2010, Rastogi A, Gastrointest Endosc 2011, Wani S, Dig Dis Sci 2011 Time consuming and increases risk of needle-stick injury Controlled expression of aspirate onto slides

10 SLOW PULL Gradual withdrawal of stylet as needle is repeatedly passed through the target lesion Low level of negative pressure within needle facilitates tissue acquisition and limits bloodiness Retrospective analysis of 97 patients biopsied with 25G needle, lower cellularity, lower bloodiness but higher diagnostic sensitivity Nakai Y, Dig Dis Sci 2014 Prospective evaluatio of 133 FNA of different origin, 22G ProCore needle, 83% yield, histological architecture in 76%, sensitivity for malignancy 85% Paik WH, J Clin Gastroenterol 2014

11 NUMBER OF PASSES Aim to obtain diagnostic specimen using the fewest number of passes to reduce time and complications Adequate number of passes should be performed to avoid repeat procedures On-site pathology vs. gross visual assessment 7 passes in pancreas and 5 passes of lymph nodes results in 83% and 77% sensitivity (first pass 17%) LeBlanc JK, Gastrointest Endosc FNAs at multiple location, 90% adequacy obtained with 6 passes with only marginal increment in obtaining adequate samples Jhala NC, Cancer 2004 Recommendation >5 passes for pancreas and 3 for lymph nodes Polkowski M, Endoscopy 2012

12 CYTOPATHOLOGY Sample processing Cytology on slides (air dry or alcohol, LBC) Cell block (recover in liquid, spin and embed in paraffin) Core for histology (formol and paraffin) Cytolyt, Dedicated experienced pathologist as part of the team

13 ROSE Rapid on-site evaluation Metaanalysis, presence of on-site cytopathology increases tissue adequacy by 3.5%-10%, but has no impact on diagnostic accuracy Dig Dis Sci 2013, 2014 Not available in many centers due to time commitment, cost, inadequate reimbursement Cytomorphology training for endosonographers Hayashi T, J Gastroenterol Hepatol 2013 Gross visual assessment can readily predict an inadequate specimen Nguyen YP, Gastroentest Endosc 2009

14 EUS NEEDLES Hollow needle, solid removable stylet, protective sheath, handle, suction syringe Characteristics Size Design (standard, trucut, reverse bevel, beveled/round stylet, type of sheath) Visibility, flexibility/stiffness, sharpness of end, friction Brands

15 SIZE Gauge 19G (0.912 mm, ) 20G (0.812 mm) 22G (0.644 mm) 25G (0.455 mm)

16 22G - STANDARD Standard FNA needle Olympus (EZShot) Cook (EchoTip) Boston (Expect) Medi-Globe (SonoTip II, Sonotip Procontrole) Covidien (Beacon)

17 SIZE 25G Standard 25G Assumption of less trauma and bleeding, more flexibility

18 25G vs 22G CONVENTIONAL FNA Prospective, randomized, multicenter study 22G 25G P value No of pts Sensitivity 94.1% 94.1% Specificity 95.8% 100% Vizualization + - < Performance + - < No of slides + - <0.05 No of cells + + Vilmann P, Scand J Gastroenterol 2013

19 25G vs 22G CONVENTIONAL FNA Randomized trial with129 lesions Same efficiency, ssuccessful crossover to 25G in 4 uncinate lesions Camellini L, Endoscopy 2011 RCT in 188 patients, comparable diagnostic accuracy 25G easier to manipulate and fewer complications (P 0.004) Lee JK, Scand J Gastroenterol 2013 Meta-analysis comparing 19, 22, 25G in pancreas 25G better adequacy to 22G, but same accuracy, no of passes and complications Affolter KE, Dig Dis Sci 2013 Meta-analysis comparing 22 and 25G of pancreas, diagnostic sensitivity of 25G significantly better (85% vs 93%, P ) Madhoun MF, Endoscopy 2013

20 HISTOLOGY OVER CYTOLOGY Aspiration (FNA): Cells Cytology Adequacy of FNA in subepithelial lesion around 50% Mekky MA, Gastrointest Endosc 2010 Biopsy (FNB): Core of tissue Histology Tissue architecture and immunohistochemistry Differentiated pancreatic cancer Lymphoma Submucosal stromal tumors Autoimmune pancreatitis Liver biopsy Eliminates the need for on-site pathologist/easier for pathologist

21 HISTOLOGY OVER CYTOLOGY Giemsa HE 5x HE 10x HE 100x

22 HISTOLOGY OVER CYTOLOGY HE CK7 p53 HE C-kit

23 HISTOLOGY NEEDLES Standard 19G needle Trucut biopsy needles Older trucut needles QuicCore (Cook) Reversed bevel needles ProCore (Cook)

24 19G - STANDARD Standard 19G needle (large size, large channel, large sample) Fluid aspiration for analysis (pancreatic cystic lesions) Therapeutic procedures with wire (pseudocyst drainage) Biopsy RCT in 117 patients, 19G vs 22G, superior accuracy and tissue acquisition, but failure in head + size, - rigidity, damage/bleeding? Song TJ, Am J Gastroenterol 2010

25 19G TRUCUT BIOPSY Trucut biopsy Old type trucut needle Binmoeller KF, Gastrointest Endosc 1998, Wiersema MJ, Gastrointest Endosc 2002 QuickCore (Cook) Animal model Wiersema MJ, Gastrointest Endosc 2002 Retrospective analysis of 19 patients, comparable, better in stromal lesion and lymphoma, but fewer passes Levy MJ, Gastrointest Endosc 2003 Comparison of TCB to FNA in 18 patients (accuracy 78% vs 89%, adequacy 83% vs 100%, bleeding and mediastinitis) Varadarajulu S, Endoscopy 2004

26 REVERSE BEVEL Reverse bevel Core trap at tip receives tissue sample while reverse bevel promotes sample collection by shearing material from lesion during retrograde movement of the needle Assumption of higher chance of obtaining core sample for histology than with a conventional FNA needle ProCore (Cook)

27 19G PROCORE 19G ProCore (Cook) Feasibility and yield in 114 lesions Feasibility 98.2%, adequacy 89.5%, correct dg. 86% Difficult insertion in 17,5% (duodenum), however 33/35 duodenal punctures feasible (needle often out in stomach), no complications Iglesias Garcia J, Gastroint Endosc 2011

28 22G PROCORE VS STANDARD FNA Randomized comparison study of 145 lesions in 144 patients 22G ProCore FNB and 22G conventional FNA in every patient, order of needle determined by randomization FNB FNA P value Feasibility 100% 100% NS No of passes 1.2± ±0.9 p<0.001 Adequacy 86.2% 87.6% 0.72 Correct dg. 79.1% 80.6% 0.73 Quality 68.9% 66.1% NS Hucl T, Endoscopy 2013

29 22G PROCORE VS STANDARD FNA Hucl T, Endoscopy 2013

30 FLEXIBLE 19G Flex 19 (Boston), nitinol Multicenter randomized trial comparing 19G flex and 25G needles for FNA of solid pancreatic masses Diagnostic accuracy, technical failure comparable and complications Histological core in 88% and 44% (P 0.001) Blood 36% vs 4% (P 0.001) Ramesh J, Pancreas 2015

31 CYTOLOGY AND HISTOLOGY Combination of cytology and histology Sensitivity for malignancy Cytology 68.1% Histology 60% Combination 89.9% (P 0.007, ) Moller K, Gastrointest Endosc 2009

32 CONCLUSIONS EUS-FNA is a powerful tool with high yield (sensitivity up 90%) Multistep process (proper indication, technique of biopsy, needle selection, establishing diagnosis by pathologist) Experience of endoscopist with his technique of key importance, variation of technique important, however strict general recommendations do not exist Some situations require specific needles, in many situations different needles may be used with similar results Histology is preferred over cytology in selected patients; further development is needed Cytology needles good ability to provide histology and combination of cytology and histology increases yield It remains to be seen whether 100% sensitivity may be reached, however lesions may not let us

33 CONCLUSIONS

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