Use and Abuse of Onsite Adequacy for EUS-FNA of the Pancreas

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Use and Abuse of Onsite Adequacy for EUS-FNA of the Pancreas Nirag Jhala MD Director of Cytopathology Perelman Center for Advanced Medicine Surgical Pathologist- GI Subspecialty Dept of Path and Lab Medicine University of Pennsylvania

Tumor Location EUS imaging More bang for the Buck? Tumor Size - Prognostication Tumor Extent Vascular Involvement Resectability Staging : Tumor, Lymph Node, Metastasis Cost Efficiency

EUS Imaging EUS images to an extent can provide information on tissue architecture

Early Detection Is The Key To Success T.S: > 0.5 cms T.S: > 2.0 cms Resections = 150/530 tumors (28%) Stage: 1A 9 (6%) 1B 21 (14%) 2A 30 (20%) 2B 84 (56%) Unknown 8 (5.3%)

CT- FNA EUS-FNA Jhala N et al AJCP 2003;120:351-67.

AACR 2004

Jhala N et al AJCP 2003;120:351-67. CT- FNA EUS-FNA Endosonography 2011. Chapter 21 Unsat Positive Negative Atypical Total Cases Percutaneous FNA 13% 42% 26% 19% 84 (100%) (1990-1999) EUS-FNA 3% 66% 25% 6% 96 (100%) (2000-2002)

Acquisition of adequate cytology sample holds key to the success for improved diagnostic accuracy for EUS-FNA of the pancreas

Qian and Hecht suggested that US/CT-guided biopsies may be more accurate and sensitive for documenting malignancy than EUS, but noted that EUS-guidance was used in more difficult lesions [41]. In contrast,. Jhala et al. demonstrated that EUS-FNA was superior to CT-FNA in obtaining adequate cells from neuroendocrine tumors of the pancreas for the diagnosis and performing additional imunohistochemical stains [42].

EUS-FNA of the Pancreas Factors that help Improve Diagnostic Performance Endosonographers experience Lesion Location ( Uncinate lesions harder then pancreas head lesions) Cytopathologist experience Onsite Adequacy Communication between endosonographers and cytopathologists Understanding access to pancreas will help reduce pitfalls 1. Cytopathology 2007;18:143-50. 2. Cancer 2004; 110: 239-46; 3. Ann Diagn Pathol. 2007;11:176-81. 4. Am J Clin Pathol 2003; 102:351-67.

What Impacts Adequacy Onsite Assessment Operator Experience Technical Difficulties Type of Needle Lesion Location Number of Passes Adequate Sample Interpretation

Factors Impacting Adequacy Cancer (Cancer Cytopathol) 2004;102:239 46. Pathologist Presence Reference EUS-FNAs Adequacy (%) Wiersema et al 1997 554 524 (94.6) Present Williams et al 1999 333 327 (98.2) Present Shin et al, 2002 179 156 (87.2) Absent Klapman et al, 2003 130 118 (90.7) Present 113 90 ( 79.6) Absent Jhala et al, 2004 209 201 (96) Present Cancer (Cancer Cytopathol) 2004;102:239 46.

Trend Continues Arch Pathol Lab Med. 2012;136(4):447-53.

Onsite Specimen Adequacy/ Interpretation Advantages Offered By Labs Improved specimen collection Advantage of reviewing direct smears as well as samples collected in transport medium Reduces frequency of inadequate samples Reduces frequency of indeterminate rates

Advantages of Providing Onsite Adequacy/ Interpretation Those Intangibles Improves communication with clinical teams. Provides information to clinical teams whether target lesions are sampled Allows better collection of samples Allows appropriate triage of samples Improves efficiency in health care delivery

F A negative biopsy should be confirmed by at least one repeat EUS biopsy

Advantages for Patients Reduces Procedure Times Potentially reduces complication rates Potential to reduce second visits Improves informed management decisions

On site Specimen Adequacy Pathologist Cytotechnologists Advanced Trainees Nursing Staff Endosonographers No Onsite Adequacy

Pathologists Provided Adequacy Assessments

Specimen Adequacy and Onsite Pathologists Reference EUS-FNAs Adequacy (%) Wiersema et al 1997 Williams et al 1999 Shin et al, 2002 Klapman et al, 2003 Pathologist Presence 554 524 (94.6) Present 333 327 (98.2) Present 179 156 (87.2) Variable 130 118 (90.7) Present 113 90 ( 79.6) Absent Jhala et al, 2004 209 201 (96) Present Cancer (Cancer Cytopathol) 2004;102:239 46.

Onsite Evaluation vs. No Onsite Evaluation Iglesias- Garcia et al AJG 2011 Alshohalbani et al Can J Gastroenterol 2009 NO. OF Cases Indeterminate Samples Onsite Not Onsite P VALUE 182 2.1% 10.3 % 0.02 104 23% 47% 0.001 NO. OF Cases Unsatisfactory Samples Onsite Not Onsite P VALUE Iglesias- Garcia et al AJG 2011 Alshohalbani et al Can J Gastroenterol 2009 182 1% 13 % 0.002 104 0% 17% NS

When CUSUM curve for 5 cytopathologists were assessed The lowest score was achieved by a cytopathologist who had EUS-FNA experience and specialized training in gastrointestinal pathology. Diagnostic Error Curve

So why not Pathologists? Time Commitments -Out weigh benefits Physical facilities make it impractical CT-FNA : 48.7 minutes USG- FNA: 44.4 minutes Endoscopy FNA : 56.2 minutes 88172 code does not provide enough compensation Cancer 2001 ;93(5):319-22. Significant time commitment leads to considerable disruption in workflow, both for individuals and labs. There is under compensation for adequacy assessment and diagnostic interpretation. Cancer 2004 ;102(4):203-6.

Role of Cytotechnologists

On Site Specimen Adequacy Cytotechnologists- Involvement Cytotechnologists represent a good marriage between skill and resource allocation in many settings where assistance for image guided FNAs are needed. Cancer (Cancer Cytopathol) 2012;120:177 84

Role of Cytotechnologists Onsite Adequacy Cytotechnologists and cytopathologists are comparably accurate in onsite assessments for specimen adequacy of EUS-guided pancreatic FNA. (n = 2426 from 2223 procedures) Acta Cytologica 2012;56(4):340-6.

Requires Training Cytotechnologists in interpretation of EUS-FNA samples Cytotechnologist Cytopathologist Pre Training ( n= 107) Adequacy 68% ( 73/107) 93% ( 100/ 107) P=0.008 Post Training ( n= 95) Adequacy 87% ( 83/95) 96% (91/95) P=0.23 Dig Liver Dis, 2012,44: 311 314

FNA by Cytotechnologists Lab Productivity Loss Disadvantages e.g Calculated Lab Productivity loss for 7 EUS- FNA : ($1,274.12) No service Compensation Lack of CPT codes for service by cytotechnologists Surgue C. MBA, SCT ( ASCP), CMIAC cytopathologymeeting.org/.../2011-asc-presentation

Real Time Telecytopathology

Real Time Telecytopathology Acta Cytologica 2012;56(6):669-77

Advantages Average Time spent for TeleCyP on-site diagnosis: 49.2 s (range 15-165 seconds) Concordance w final cytopathology diagnoses in 35 /38 (92%) cases Offers advantage of specimen adequacy by a pathologist Potential to harness the talents of advanced trainee as well as cytotechnologists Acta Cytologica 2012;56(6):669-77

Telecytopathology Advantages Cytotechnologist/ Trainees Mean Time Conventional 1.1 h 1.1 h Pathologist.73.2 h Mean Time TeleCyP Utilized Judiciously TeleCyP can result in substantial time saving Provides Cost benefit scenario Acta Cytol 2012;56(5):548-53

Lesion Type and Onsite Cytology Onsite Specimen Adequacy is useful for Solid Pancreatic Lesions Onsite Specimen Adequacy has limited role in analysis of Pancreatic Cysts Cancer Cytopathol. 2013 ;121(1):4-8

Take Home Points Best Scenario would be to have Pathologists perform specimen adequacy/ interpretation Best Alternative : Real Time Telecytopathology Needs further analysis Onsite Cytology May not be of value for Cystic Pancreatic Lesions

Onsite Assessments: To offer or not to offer is the question Pathologists who report cytology should engage in personalized medicine by embracing the idea of FNA with ROSE as a point-of-care test

Onsite Diagnosis: Can or Should it be done? Diagn Pathol 2007;11:176-81.

EUS-FNA of the Pancreas A perspective from clinical colleagues In the United States, 62 EUS fellows graduate each year and several practice in secondary-size cities and hospitals that do not have access to on-site cytopathology or to cytopathologists trained to interpret EUS specimens. Despite being adequately trained, these novice endosonographers find it difficult to replicate the level of success they had experienced at their training programs. Consequently, their confidence dips, enthusiasm for EUS diminishes, referrals disappear, and practice suffers. Gastrointest Endosc. 2012;76:397-9. Clin gastro and Hep 2012;10:697 703