TY - JOUR
T1 - Increasing Number of Passes Beyond 4 Does Not Increase Sensitivity of Detection of Pancreatic Malignancy by Endoscopic Ultrasound–Guided Fine-Needle Aspiration
AU - Mohamadnejad, Mehdi
AU - Mullady, Daniel
AU - Early, Dayna S.
AU - Collins, Brian
AU - Marshall, Carrie
AU - Sams, Sharon
AU - Yen, Roy
AU - Rizeq, Mona
AU - Romanas, Maria
AU - Nawaz, Samia
AU - Ulusarac, Ozlem
AU - Hollander, Thomas
AU - Wilson, Robert H.
AU - Simon, Violette C.
AU - Kushnir, Vladimir
AU - Amateau, Stuart K.
AU - Brauer, Brian C.
AU - Gaddam, Srinivas
AU - Azar, Riad R.
AU - Komanduri, Srinadh
AU - Shah, Raj
AU - Das, Ananya
AU - Edmundowicz, Steven
AU - Muthusamy, V. Raman
AU - Rastogi, Amit
AU - Wani, Sachin
N1 - Publisher Copyright:
© 2017 AGA Institute
PY - 2017/7
Y1 - 2017/7
N2 - 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.
AB - 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.
KW - Cytopathology
KW - Endoscopic Ultrasonography
KW - Fine-Needle Aspiration
KW - Pancreatic Cancer
UR - https://www.scopus.com/pages/publications/85018384234
U2 - 10.1016/j.cgh.2016.12.018
DO - 10.1016/j.cgh.2016.12.018
M3 - Article
C2 - 28025154
AN - SCOPUS:85018384234
SN - 1542-3565
VL - 15
SP - 1071-1078.e2
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 7
ER -