DIAGNOSTIC ACCURACY OF SERUM PIVKA-II FOR EARLY DETECTION OF HEPATOCELLULAR CARCINOMA IN PATIENTS WITH LIVER CIRRHOSIS TAKING HISTOPATHOLOGY AS THE GOLD STANDARD

Abstract

Background: Hepatocellular carcinoma is one of the more severe complications of liver cirrhosis and is a disease with a high morbidity and mortality, particularly if diagnosed late. In this regard, early detection is crucial for timely treatment and improved clinical outcomes. A serum protein induced by vitamin K absence or antagonist-II (PIVKA-II) has proven to be a potential marker for HCC; however, the current evidence is limited in the local context.

Objective: To determine the diagnostic accuracy of serum PIVKA-II for the early detection of hepatocellular carcinoma in patients with liver cirrhosis, taking histopathology as the gold standard.

Methods: A cross-sectional validation study was carried out at the Department of Medicine, Capital Development Authority Hospital, Islamabad from 14^th January 2026 to 14^th April 2026. A total of 208 samples of both genders with mean age between 18 and 70 years and liver cirrhosis where the liver was felt to be suspicious for malignancy were included using a non-probability consecutive sampling technique. All interventional procedures were performed after the serum PIVKA-II level was tested. Hepatocellular carcinoma was defined as having a value of more than 62.5 mAU/ml. Histopathology was used as the gold standard. SPSS version 25 was used for data analysis. A 2x2 contingency table was used to determine sensitivity, specificity, positive predictive value, negative predictive value and overall diagnostic accuracy. The significance of a p value was defined as < 0.05.

Results: The mean age of the patients was 52.8 ± 10.6 years. There were 132 (63.5%) males and 76 (36.5%) females. Histopathology confirmed hepatocellular carcinoma in 94 (45.2%) patients, while 114 (54.8%) patients were negative for hepatocellular carcinoma. Serum PIVKA-II was positive in 68 (32.7%) patients and negative in 140 (67.3%) patients. On comparison with histopathology, 58 patients were true positive, 104 were true negative, 10 were false positive, and 36 were false negative. Serum PIVKA-II showed sensitivity of 61.7%, specificity of 91.2%, positive predictive value of 85.3%, negative predictive value of 74.3%, and overall diagnostic accuracy of 77.9%. A statistically significant association was found between serum PIVKA-II and histopathological diagnosis of hepatocellular carcinoma (p<0.001).

Conclusion: Serum PIVKA-II showed good diagnostic accuracy for detecting hepatocellular carcinoma in patients with liver cirrhosis, with high specificity and good positive predictive value. However, its moderate sensitivity indicates that a negative result cannot completely exclude hepatocellular carcinoma. Therefore, PIVKA-II may be used as a supportive diagnostic marker along with clinical assessment, imaging, and histopathological confirmation where required.