Background: Up to 70% of the cases of biliary strictures are cholangiocarcinoma. Cholangiocarcinoma has a late diagnosis and poor outcomes; therefore, effective biomarkers are needed for malignant lesions detection at earlier stages. Aim:The aim was to assess the diagnostic utility of bile pyruvate kinase M2 (PKM2) as a biomarker for the detection of malignant biliary strictures in patients with an indeterminate biliary stricture.Materials and Methods: This is a prospective study to evaluate the diagnostic value of bile PKM2 for the diagnosis of malignant biliary strictures. Bile samples were collected during Endoscopic Retrograde Cholangio Pancreatography to quantify PKM2 levels and were used to compare their diagnostic value with biliary brush cytology, endoscopic ultrasound-guided fine needle biopsy, or clinical follow-up.Results: Forty-six patients were recruited for the study; 19 patients with malignant strictures and 27 with benign biliary strictures. The bile PKM2 levels were elevated in patients with malignant biliary strictures [median 0.045 ng/mL (IQR 0.014 to 0.092)] compared with those with benign strictures [median 0.019 ng/mL (IQR 0.00 to 0.047)]. Bile PKM2 had a receiver-operating characteristic curve of 0.66 (0.49 to 0.83) with a cutoff value of bile PKM2 of 0.0017 ng/ mL. The sensitivity and specificity of bile PKM2 for the diagnosis of cholangiocarcinoma were 89% and 26%; the positive and negative predictive values were 46% and 78%, respectively. Conclusion:In patients with indeterminate biliary strictures, bile PKM2 may be a potential biomarker for the diagnosis of malignancy.

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