Validation of Decision Cut off Values of Serum Albumin and Prothrombin Time for Differentiating between Compensated and Decompensated Liver Cirrhosis

Aims: Serum bilirubin, albumin and prothrombin time are the most commonly measured parameters to assess the progress of hepatic cirrhosis. No widely accepted cut off values for these parameters are available for an early diagnosis of the decompensation process of hepatic cirrhosis. We aimed to establish the cut off values for these parameters with maximum sensitivity and minimum false positivity between 30 decompensated and 33 compensated cirrhosis patients through ROC curves for making a medical decision at the earliest.

Study Design: It was a hospital based, cross sectional, observational study. Both of the case and control groups were selected by the method of convenience.

Place and Duration of Study: Study subjects were analyzed in the Department of Medicine (Medical Unit II), Department of Biochemistry and Department of Radiology, Mamata Medical College, Khammam, Andhra Pradesh, India between Jan 2009 and Feb 2010.

Methodology: Sample: 63 patients (40 men, 23 women; age range 20-60 years) diagnosed as hepatic cirrhosis on the basis of clinical, biochemical and ultrasonographic features were included as the case group in the study. Thirty-five (35) age and sex matched normal healthy subjects were included in the control group. Patients with portal hypertension, ascitis, encephalopathy and with the medical history of gastrointestinal bleeding, were put in the decompensated group (n =30). Cases without the above criteria were selected in the compensated group (n =33).

Results: Cirrhosis patients showed significant increase in serum bilirubin level (6.79 +/- 2.19 vs 0.86 +/- 0.02, P<0.001) and prothormbin time (20.13 +/- 2.25 vs 15.54 +/- 0.63, P<0.001) with opposite trend with serum albumin (3.05 +/- 0.62 vs 3.69 +/- 0.83, P<0.001) when compared to normal control group. Furthermore, the decompensated group showed a significant rise in serum bilirubin (8.90 +/- 0.78 vs 4.80 +/- 0.79, P<0.001) and prothrombin time (21.44 +/- 2.5 vs 18.93 +/- 0.84, P<0.001) with a decrease of serum albumin (2.8 +/- 0.36 vs 3.2 +/- 0.76, P<0.027) in comparision to compensated group. ROC analysis for the serum albumin level and prothrmbin time between the compensated and decompensated groups showed their cut off values to be 2.97g/dl and 19.47 seconds respectively. No cut off value for serum bilirubin could be obtained due to non overlapping values between the two groups.

Conclusion: The calculated cuts off values of serum albumin and prothrombin time in our study indicate the transition phase between the compensatory and decompensatory groups of hepatic cirrhosis. As early detection of the decompensation process can guide the clinicians to take the proper management to reduce the complications and mortality significantly, these cut off values would provide useful diagnostic and therapeutic tools in these patients.