A randomized comparison of EUS-guided FNA versus CT or US-guided FNA for the evaluation of pancreatic mass lesions

Gastrointest Endosc. 2006 Jun;63(7):966-75. doi: 10.1016/j.gie.2005.09.028.

Abstract

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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adenocarcinoma / diagnostic imaging
  • Adenocarcinoma / pathology*
  • Aged
  • Algorithms
  • Biopsy, Fine-Needle / methods*
  • Cross-Over Studies
  • Endoscopy, Gastrointestinal / methods
  • Endosonography*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pancreatic Neoplasms / diagnostic imaging
  • Pancreatic Neoplasms / pathology*
  • Prospective Studies
  • Sensitivity and Specificity
  • Tomography, X-Ray Computed*