Predictors of malignancy in pancreatic head mass: a prospective study.

The objective of the study was to identify the predictive factors for malignancy in pancreatic head mass as a primary outcome and assess the value of CA 19-9 as a diagnostic tool for malignancy as a secondary outcome. A prospective study of patients presented with pancreatic head mass was conducted in a tertiary care referral hospital, Manipal, India from May 2006 to November 2008. The study population was divided into malignant and benign groups based on the final histopathology report. A univariate and multivariate analysis of potential predictive factors for malignancy were conducted. A total of 102 patients with pancreatic head mass were included in the study after fulfilling the inclusion/exclusion criteria. 78 were malignant and 24 were benign. There was significant weight loss (p<0.001) and high mean bilirubin levels (p=0.002) in the malignant group. Mean CA 19-9 was significantly higher in the malignant group (290.7 vs. 30.3 U/ml; p<0.001). Sensitivity and specificity of CA 19-9 for detecting malignancy in pancreatic head mass at a cut off of 35 U/ml was 86% and 79% respectively. CA 19-9 positivity rate was higher with increasing cut off values of 100, 200 and 300 U/ml but such high levels occurred in fewer patients. All the non-jaundiced patients (100%) with raised CA 19-9 levels were found to be malignant compared to 86% malignancy in jaundiced patients. In multivariate analysis, a combination of weight loss>10% of body weight and bilirubin>3 mg/dl and CA 19-9>35 U/ml had specificity and positive predictive value of 100% for predicting malignancy in pancreatic head mass. The presence of weight loss and jaundice and raised CA 19-9 levels together in a patient with pancreatic head mass can be predictive of malignancy. A very high CA 19-9 level can be an indicator of malignancy in a pancreatic head mass. A raised CA 19-9 level may be more predictive of malignancy in non-jaundiced patients than in jaundiced patients.