The level of carcinoembryonic antigen (CEA) in the bile of 17 patients with benign pancreatic and biliary diseases and 50 patients with pancreatic and biliary cancer were determined by enzyme immunoassay. The bile specimens were obtained at the time of percutaneous transhepatic cholangiography. The bile was centrifuged and the supernatant was used for CEA measurement, while the cell pellet was examined cytologically. High CEA values in the bile were significantly more frequent in patients with pancreatic and biliary cancer than in those with benign pancreatic or biliary diseases; increased CEA concentrations in the bile were observed in 76.0% and 60.0%, respectively, of all the patients and of the patients with localized cancer. The location of the cancer had no influence on the bile CEA level, but the CEA levels in the bile tended to be high when the tumor had distant metastases, or when the biliary tract was completely obstructed. Although patients with pancreatic and biliary cancer had a high CEA value in the bile significantly more frequently, bile CEA measurement is not sufficient to distinguish an individual patient with pancreatic or biliary cancer from those with other disease, since the overlap between the values is too great, and therefore, additional examinations are required. Correct diagnosis of malignancy were made by cytological examination alone, by bile CEA assay alone and visual examination of dye in the biliary tract alone in 72.0, 76.0, and 88.0%, respectively, of the patients examined, while a combination of these methods raised the diagnostic rate to 100%.