A randomized comparison of EUS-guided FNA versus CT or US-guided FNA for the evaluation of pancreatic mass lesions.
BACKGROUND
Diagnosing pancreatic cancer by EUS-FNA is a potentially appealing alternative to percutaneous biopsy.


OBJECTIVE
To compare EUS-FNA with CT or US-guided FNA for diagnosing pancreatic cancer.


METHODS
Single center, prospective, randomized, cross-over.


METHODS
Duke University Medical Center.


METHODS
Eighty-four patients referred with suspicious solid pancreatic mass lesions randomized to CT/US-FNA (n = 43) or EUS-FNA (n = 41).


METHODS
Patients underwent an imaging procedure/FNA. If cytology was nondiagnostic, cross over to the other modality was offered. Final outcome was determined by clinical follow-up every 6 months for 2 years and/or surgical pathology for patients with negative FNA.


METHODS
Sensitivity and accuracy of EUS-FNA versus CT/US-FNA for pancreatic cancer.


RESULTS
There were 16 true positive (TP) by CT/US-FNA and 21 TP by EUS-FNA. Sixteen of the 20 CT/US-FNA negative patients crossed over to EUS-FNA; 12 underwent FNA, 4 had no mass at EUS. Seven of the 12 had positive EUS-FNA. Eight EUS-FNA negative crossed over to CT/US; 4 had no mass at CT/US, 3 remained true negative throughout follow-up, 1 had chronic pancreatitis at surgery. The sensitivity of CT/US-FNA and EUS-FNA for detecting malignancy was 62% and 84%, respectively. A comparison of the accuracy for CT/US-FNA and EUS-FNA was not statistically significant (P = .074, chi(2)).


CONCLUSIONS
Failure to meet target enrollment resulted in an inability to demonstrate a statistically significant difference between the 2 modalities.


CONCLUSIONS
EUS-FNA is numerically (though not quite statistically) superior to CT/US-FNA for the diagnosis of pancreatic malignancy.
Horwhat
John David
JD
Department of Medicine, Walter Reed Army Medical Center, 6900 Georgia Avenue NW, Washington, DC 20307, USA.
Paulson
Erik K
EK
McGrath
Kevin
K
Branch
M Stanley
MS
Baillie
John
J
Tyler
Douglas
D
Pappas
Theodore
T
Enns
Robert
R
Robuck
Gail
G
Stiffler
Helen
H
Jowell
Paul
P
D000230:Adenocarcinoma / Q000000981:diagnostic imaging / Q000473:pathology*; D000368:Aged; D000465:Algorithms; D044963:Biopsy, Fine-Needle / Q000379:methods*; D018592:Cross-Over Studies; D016099:Endoscopy, Gastrointestinal / Q000379:methods; D019160:Endosonography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D014057:Tomography, X-Ray Computed