Plasma elimination of cholyl-lysyl-fluorescein (CLF): a pilot study in patients with liver cirrhosis

Background: Cholyl-lysyl-fluorescein (CLF) is a fluorescein-labelled bile a cid whose biological behaviour closely resembles that of naturally occurrin g cholyl glycine. Aim: The aim of this study was to analyze the CLF plasma elimination in patients with liver cirrhosis. Methods: A dose of CLF at 0.0 2 mg/kg b.w. was administered i.v. in 26 patients with liver cirrhosis and 9 healthy volunteers. Blood samples were collected before injection and the n at 10 min intervals over 60 min. Plasma fluorescence was measured by a lu minescence spectrometer and residual fluorescence over the time of the stud y was compared in each group. Routine liver function tests (rLFTs) were per formed before each injection. Results: Plasma elimination of CLF was signif icantly impaired in patients with cirrhosis compared to healthy subjects wi th p values <0.0001 at each analyzed time point. CLF test showed 100% sensi tivity for liver cirrhosis when residual fluorescence was measured 30, 40, 50 and 60 min after injection. Routine LFTs showed 85% sensitivity for bili rubin, 84% for total bile acids, 69% for aspartate aminotransferase 62% for albumin and 50% for alkaline phosphatase. CLF elimination measured 60 min after injection correlated with Child-Pugh score (r=0.3945; p<0.05) and alb umin (r(s)=0.6451; p<0.001). No adverse reaction or side effects of CLF wer e observed. Conclusions: CLF test clearly distinguished between the two ana lyzed groups and was more sensitive than routine liver function tests. The test appears safe, simple to perform and analyze and after validation in la rger cohorts of patients may have the potential to become a useful dynamic test of liver function.