Differentiation between benign and malignant hilar obstructions using laboratory and radiological investigations: a prospective study.

BACKGROUND Preoperative determination of the aetiology of bile duct strictures at the hilum is difficult. We evaluated the diagnostic accuracy of laboratory parameters and imaging modalities in differentiating between benign and malignant causes of hilar biliary obstruction. PATIENTS AND METHODS Fifty-eight patients (26 men) with a history of obstructive jaundice and liver function tests (LFTs) and ultrasound suggestive of biliary obstruction at the hilum were studied. They were evaluated by tumour marker assay (CA19-9), CT and MRI/MRCP. A single experienced radiologist, blinded to the results of other tests, evaluated the imaging. The final diagnosis was made either from histology of the resected specimen, operative findings or image-guided biopsy in inoperable patients. A receiver operator characteristic (ROC) curve was constructed for each laboratory parameter to determine optimal diagnostic cut-off to predict malignant biliary stricture (MBS). RESULTS In all, 34 patients had a benign and 24 had malignant aetiology. The mean age of benign patients was 38 years compared with 54 years for MBS. Forty-seven patients were treated with surgery while 11 had ERCP/PTC and stenting. The ROC curve showed that preoperative bilirubin level >8.4 mg/dl (sensitivity 83.3%, specificity 70%), alkaline phosphatase level >478 IU (sensitivity 63%, specificity 49%) and CA19-9 levels >100 U/L (sensitivity 45.8%, specificity 88.2%) for predicting MBS. The sensitivity, specificity and diagnostic accuracy of MRI/MRCP (87.5%, 85.3%, 82.7%, respectively) was marginally superior to CT (79.2%, 79.4%, 79.3%, respectively). CONCLUSIONS Patients with a bilirubin level of >8.4 mg% and CA19-9 level >100 U/L were more likely to have malignant aetiology. MRI/MRCP was a better imaging modality than CT.