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. AIM: To compare EUS-FNA with CT or US-guided FNA for diagnosing pancreatic cancer. DESIGN: Single center, prospective, randomized, cross-over. SETTING: Duke University Medical Center. POPULATION: Eighty-four patients referred with suspicious solid pancreatic mass lesions randomized to CT/US-FNA (n = 43) or EUS-FNA (n = 41). INTERVENTION: 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. MAIN OUTCOME MEASUREMENTS: 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)). LIMITATIONS: 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.

Duke Scholars

Author Erik Karl Paulson Radiology, Abdominal Imaging

Author Malcolm Stanley Branch Medicine, Gastroenterology

Author Theodore N. Pappas Surgery, Minimally Invasive Surgery

Author Paul Simon Jowell Medicine, Gastroenterology