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Increasing Number of Passes Beyond 4 Does Not Increase Sensitivity of Detection of Pancreatic Malignancy by Endoscopic Ultrasound–Guided Fine-Needle Aspiration Publisher Pubmed



Mohamadnejad M1, 2 ; Mullady D3 ; Early DS3 ; Collins B3 ; Marshall C4 ; Sams S4 ; Yen R4 ; Rizeq M4 ; Romanas M5 ; Nawaz S4 ; Ulusarac O5 ; Hollander T3 ; Wilson RH4 ; Simon VC4 Show All Authors
Authors
  1. Mohamadnejad M1, 2
  2. Mullady D3
  3. Early DS3
  4. Collins B3
  5. Marshall C4
  6. Sams S4
  7. Yen R4
  8. Rizeq M4
  9. Romanas M5
  10. Nawaz S4
  11. Ulusarac O5
  12. Hollander T3
  13. Wilson RH4
  14. Simon VC4
  15. Kushnir V3
  16. Amateau SK4
  17. Brauer BC4
  18. Gaddam S3
  19. Azar RR3
  20. Komanduri S6
  21. Shah R4
  22. Das A7
  23. Edmundowicz S4
  24. Muthusamy VR1
  25. Rastogi A5
  26. Wani S4
Show Affiliations
Authors Affiliations
  1. 1. University of California, Los Angeles, Los Angeles, California, United States
  2. 2. Liver and Pancreatobiliary Disease Research Center, Digestive Disease Research Institute, Tehran University of Medical Science, Tehran, Iran
  3. 3. Washington University School of Medicine, St. Louis, Missouri, United States
  4. 4. University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
  5. 5. Kansas City VA Medical Center and University of Kansas, Kansas City, Missouri, United States
  6. 6. Feinberg School of Medicine, Northwestern University, Chicago, Illinois, United States
  7. 7. Arizona Center for Digestive Health, Gilbert, Arizona, United States

Source: Clinical Gastroenterology and Hepatology Published:2017


Abstract

Background & Aims It is not clear exactly how many passes are required to determine whether pancreatic masses are malignant using endoscopic ultrasound–guided fine-needle aspiration (EUS-FNA). We aimed to define the per-pass diagnostic yield of EUS-FNA for establishing the malignancy of a pancreatic mass, and identify factors associated with detection of malignancies. Methods In a prospective study, 239 patients with solid pancreatic masses were randomly assigned to groups that underwent EUS-FNA, with the number of passes determined by an on-site cytopathology evaluation or set at 7 passes, at 3 tertiary referral centers. A final diagnosis of pancreatic malignancy was made based on findings from cytology, surgery, or a follow-up evaluation at least 1 year after EUS-FNA. The cumulative sensitivity of detection of malignancy by EUS-FNA was calculated after each pass; in the primary analysis, lesions categorized as malignant or suspicious were considered as positive findings. Results Pancreatic malignancies were found in 202 patients (84.5% of the study population). EUS-FNA detected malignancies with 96% sensitivity (95% confidence interval [CI], 92%–98%); 4 passes of EUS-FNA detected malignancies with 92% sensitivity (95% CI, 87%–95%). Tumor size greater than 2 cm was the only variable associated with positive results from cytology analysis (odds ratio, 7.8; 95% CI, 1.9–31.6). In masses larger than 2 cm, 4 passes of EUS-FNA detected malignancies with 93% sensitivity (95% CI, 89%–96%) and in masses ≤2 cm, 6 passes was associated with 82% sensitivity (95% CI, 61%–93%). Sensitivity of detection did not increase with increasing number of passes. Conclusions In a prospective study, we found 4 passes of EUS-FNA to be sufficient to detect malignant pancreatic masses; increasing the number of passes did not increase the sensitivity of detection. Tumor size greater than 2 cm was associated with malignancy, and a greater number of passes may be required to evaluate masses 2 cm or less. ClinicalTrials.gov number, NCT01386931. © 2017 AGA Institute