Objective To evaluate the validity of a serum carbohydrate antigen 19-9(CA19-9) determination in the diagnosis of extrahepatic cholangiocarcinoma(EHCC). Methods Serum CA19-9 concentration and serum carcinoembryonic antigen(CEA) concentration were prospectively measured by an immunoradiometric assay without knowledge of the clinical diagnosis in patients with EHCC (n=51), benign biliary diseases (n=42), and healthy individuals (n=15). Using a receiver operating characteristic (ROC) curve define a new strategy for interpreting CA19-9 and CEA in EHCC. Results The sensitivity of CA19-9 and CEA in diagnosing EHCC were 86.3% (44/51) and 25.5%(13/51), respectively. When compared with the benign biliary diseases group, the true negative rates of serum CA19-9 and serum CEA were 85.7% (36/42) and 95.2%(40/42), respectively. The false positive rates of serum CA19-9 and serum CEA were 14.3 %( 6/42) and 4.8 %( 2/42), whereas the accuracy of serum CA19-9 and serum CEA were 57.0%(53/93) and 86.0%(80/93), respectively. Serum CA19-9 concentration and serum CEA concentration were significantly elevated (P0.05), respectively. In 22 patients undergoing curative resection of EHCC, the mean serum CA19-9 concentration decreased from preoperative level of (456.6±120.4) kU·L-1 to postoperative level (62.8±17.3) kU·L-1(P<0.001). The outcomes showed that serum CA19-9 had greater diagnosis performances than serum CEA. Conclusion Serum CA19-9 is an effective tumor marker in diagnosing of cholangiocarcinoma, deciding whether the tumor has been radically resected and monitoring effect of treatment
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