Prospective evaluation of the contribution of K-ras mutational analysis and CA 19.9 measurement to cytological diagnosis in patients with clinical suspicion of pancreatic cancer

The aim of this study was to prospectively evaluate the diagnostic contribu tion of the detection of K-ins mutation and measurement of serum CA 19.9 co ncentrations to cytological diagnosis in patients with clinical suspicion o f pancreatic cancer. These patients had either the presence or absence of a pancreatic mass as determined by imaging procedures. A total of 156 consec utive patients with clinical suspicion of pancreatic cancer or for confirma tion and follow-up of their chronic pancreatitis disease were included: 84 patients presenting a pancreatic mass (group 1) and 72 patients without a p ancreatic mass (group 2). K-ras mutations were detected by a restriction fr agment length polymorphism/polymerase chain reaction (RFLP/PCR) method and CA 19.9 by an immunoluminometric assay. When a pancreatic mass was present, cytology offered a high sensitivity, but with a significant number of inco nclusive results and K-ras mutational analysis offered a highly specific te st. In the absence of a pancreatic mass, CA 19.9 (cut-off 100 U/ml) increas ed the sensitivity of the diagnosis by cytology and K-ras mutational analys is did not add significant information. Thus both tests contribute to the c linical decision process when pancreatic cancer is clinically suspected and the cytological report is not conclusive. (C) 2000 Elsevier Science Ltd. A ll rights reserved.