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

Mehdi Mohamadnejad, Daniel Mullady, Dayna S. Early, Brian Collins, Carrie Marshall, Sharon Sams, Roy Yen, Mona Rizeq, Maria Romanas, Samia Nawaz, Ozlem Ulusarac, Thomas Hollander, Robert H. Wilson, Violette C. Simon, Vladimir Kushnir, Stuart K. Amateau, Brian C. Brauer, Srinivas Gaddam, Riad R. Azar, Srinadh KomanduriRaj Shah, Ananya Das, Steven Edmundowicz, V. Raman Muthusamy, Amit Rastogi, Sachin Wani

Research output: Contribution to journalArticlepeer-review

27 Scopus citations

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.

Original languageEnglish
Pages (from-to)1071-1078.e2
JournalClinical Gastroenterology and Hepatology
Volume15
Issue number7
DOIs
StatePublished - Jul 2017

Keywords

  • Cytopathology
  • Endoscopic Ultrasonography
  • Fine-Needle Aspiration
  • Pancreatic Cancer

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