title: Increasing Number of Passes Beyond 4 Does Not Increase Sensitivity of Detection of Pancreatic Malignancy by Endoscopic Ultrasound-Guided Fine-Needle Aspiration.
abstract: OBJECTIVE
  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.
authors.affiliation: University of California, Los Angeles, Los Angeles, California; Liver and Pancreatobiliary Disease Research Center, Digestive Disease Research Institute, Tehran University of Medical Science, Tehran, Iran.
authors.forename: Mehdi
authors.initials: M
authors.lastname: Mohamadnejad
authors.affiliation: Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Daniel
authors.initials: D
authors.lastname: Mullady
authors.affiliation: Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Dayna S
authors.initials: DS
authors.lastname: Early
authors.affiliation: Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Brian
authors.initials: B
authors.lastname: Collins
authors.affiliation: University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Carrie
authors.initials: C
authors.lastname: Marshall
authors.affiliation: University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Sharon
authors.initials: S
authors.lastname: Sams
authors.affiliation: University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Roy
authors.initials: R
authors.lastname: Yen
authors.affiliation: University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Mona
authors.initials: M
authors.lastname: Rizeq
authors.affiliation: Kansas City VA Medical Center and University of Kansas, Kansas City, Missouri.
authors.forename: Maria
authors.initials: M
authors.lastname: Romanas
authors.affiliation: University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Samia
authors.initials: S
authors.lastname: Nawaz
authors.affiliation: Kansas City VA Medical Center and University of Kansas, Kansas City, Missouri.
authors.forename: Ozlem
authors.initials: O
authors.lastname: Ulusarac
authors.affiliation: Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hollander
authors.affiliation: University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Wilson
authors.affiliation: University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Violette C
authors.initials: VC
authors.lastname: Simon
authors.affiliation: Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Kushnir
authors.affiliation: University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Stuart K
authors.initials: SK
authors.lastname: Amateau
authors.affiliation: University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Brian C
authors.initials: BC
authors.lastname: Brauer
authors.affiliation: Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Srinivas
authors.initials: S
authors.lastname: Gaddam
authors.affiliation: Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Riad R
authors.initials: RR
authors.lastname: Azar
authors.affiliation: Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Srinadh
authors.initials: S
authors.lastname: Komanduri
authors.affiliation: University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Raj
authors.initials: R
authors.lastname: Shah
authors.affiliation: Arizona Center for Digestive Health, Gilbert, Arizona.
authors.forename: Ananya
authors.initials: A
authors.lastname: Das
authors.affiliation: University of Colorado Anschutz Medical Campus, Aurora, Colorado.
authors.forename: Steven
authors.initials: S
authors.lastname: Edmundowicz
authors.affiliation: University of California, Los Angeles, Los Angeles, California.
authors.forename: V Raman
authors.initials: VR
authors.lastname: Muthusamy
authors.affiliation: Kansas City VA Medical Center and University of Kansas, Kansas City, Missouri.
authors.forename: Amit
authors.initials: A
authors.lastname: Rastogi
authors.affiliation: University of Colorado Anschutz Medical Campus, Aurora, Colorado. Electronic address: sachinwani10@yahoo.com.
authors.forename: Sachin
authors.initials: S
authors.lastname: Wani
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044963:Biopsy, Fine-Needle / Q000379:methods*; D019160:Endosonography / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000175:diagnosis*; D010190:Pancreatic Neoplasms / Q000175:diagnosis*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D062606:Tertiary Care Centers
keywords: Cytopathology; Endoscopic Ultrasonography; Fine-Needle Aspiration; Pancreatic Cancer