To evaluate the clinical value in diagnosis of biliary and pancreatic cancer carcinoembryonic antigen (CEA), carbohydrate antigen (CA19-9) and cytology in the bile were examined in 343 patients with benign biliary disease and 71 patients with biliary and pancreatic cancer. An abnormal CEA level was defined as a level of more than 500 ng/ml in the gallbladder bile and 40 ng/ml in the bile duct bile. Increased bile CEA levels were observed in 50.0% in 22 patients with bile duct cancer, 60.0% in 20 with gallbladder cancer and 23.8% in 21 with pancreas cancer. False positive rate in 343 patients with benign diseases was only 1.2%. Bile CA19-9 levels were measured in 195 patients with benign disease and 30 with malignancy. However, the overlap between the values of the 2 groups was too great for differentiation of malignancy from benign disease. The positive rates of bile cytology were 52.2% in 23 patients with bile duct cancer, 40.0% in 15 with gallbladder cancer and 27.3% in 22 with pancreatic cancer. The diagnostic accuracies of combined assessment of bile CEA and cytology were 68.0% in 25 patients with bile duct cancer, 77.3% in 22 with gallbladder cancer and 37.5% in 24 with pancreatic cancer. The sensitivity of this combined test was 60.6% (43/71), and the specificity was 98.8% (339/343). This combined test is considered to be reliable screening test especially for biliary cancer.