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Randomized Controlled Trial
. 2017 Jul;15(7):1071-1078.e2.
doi: 10.1016/j.cgh.2016.12.018. Epub 2016 Dec 23.

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

Mehdi Mohamadnejad  1 , Daniel Mullady  2 , Dayna S Early  2 , Brian Collins  2 , Carrie Marshall  3 , Sharon Sams  3 , Roy Yen  3 , Mona Rizeq  3 , Maria Romanas  4 , Samia Nawaz  3 , Ozlem Ulusarac  4 , Thomas Hollander  2 , Robert H Wilson  3 , Violette C Simon  3 , Vladimir Kushnir  2 , Stuart K Amateau  3 , Brian C Brauer  3 , Srinivas Gaddam  2 , Riad R Azar  2 , Srinadh Komanduri  5 , Raj Shah  3 , Ananya Das  6 , Steven Edmundowicz  3 , V Raman Muthusamy  7 , Amit Rastogi  4 , Sachin Wani  8
Affiliations
Randomized Controlled Trial

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

Mehdi Mohamadnejad et al. Clin Gastroenterol Hepatol. 2017 Jul.

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.

Keywords: Cytopathology; Endoscopic Ultrasonography; Fine-Needle Aspiration; Pancreatic Cancer.

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