Prediction Of Clinical Outcome In Patients With Cirrhosis By Indocyanine Green Clearance Test And Comparison Of Testing Instruments

Objective:Liver reserve function is the ability of the liver to metabolize,repair,and regenerate,and reflects the liver’s ability to tolerate injury.Current molecular markers and scoring systems still have limitations in reflecting liver reserve function.Indocyanine green（ICG）clearance test can reflect the liver reserve function in liver injury dynamically and accurately and is now widely used in clinical practice.Cirrhosis is a pathological stage in the progression of chronic liver disease and has high clinical morbidity and mortality;Acute-on-chronic liver failure（ACLF）is a kind of acute liver failure caused by multiple triggers based on chronic liver disease and is a common critical liver disease in clinical practice,both of which often have poor liver reserve function and severe hepatocyte damage.Therefore,early assessment of disease severity for early intervention is essential to improve the prognosis of patients.This study explores the predictive value of the ICG clearance test on clinical outcomes in patients with cirrhosis and ACLF and conducts a comparative study on the parameters of the domestic Yatai Zhongke SNT-1000 pigment concentration map analyzer and the Japanese photoelectric DDG-3300K pigment concentration analyzer.Methods:1、272 patients with cirrhosis who underwent ICG clearance tests during hospitalization in the Department of Hepatobiliary and Pancreatic Medicine of the First Hospital of Jilin University were collected,234 of whom had complete clinical data（January 2021 to June 2022）.Basic patient information,ICG clearance test parameters,laboratory indices,and imaging examinations were collected,and MELD,MELD-Na,and CTP prognostic scores were calculated.The 234 patients were followed up and counted for progression to liver failure（LF）at 3 and 6 months and non-progression periods.The ICG clearance test parameters,laboratory indicators,and prognostic scores of cirrhotic patients were analyzed univariately and predictive models were constructed using IBM SPSS 27.0 software and plotted using Graph Pad Prism9 software.2、84 patients with ACLF who underwent ICG clearance tests during hospitalization in the Department of Hepatobiliary and Pancreatic Medicine of the First Hospital of Jilin University were collected,72 of whom had complete clinical data（January 2020 to March 2022）.Basic patient information,ICG clearance test parameters,laboratory indices,and imaging examinations were collected,and MELD,MELD-Na,CTP,and KCH standard prognostic scores were calculated.The 72patients were followed up and counted for death at 3 and 6 months and survival periods.The ICG clearance test parameters,laboratory indicators,and prognostic scores of ACLF patients were analyzed univariately and predictive models were constructed using IBM SPSS 27.0 software and plotted using Graph Pad Prism9software.3、A total of 206 inpatients and outpatients who visited the Department of Hepatobiliary and Pancreatic Medicine of our hospital from January 2022 to January2023 who also applied different pigment concentration analyzers（Japan Photoelectric DDG-3300K pigment concentration analyzer and Yatai Zhongke SNT-1000 pigment concentration map analyzer）for ICG clearance test were enrolled,and the parameters of the two ICG clearance tests were recorded and grouped according to ICG R15.The patients were divided into groups（ICG R15≤10%、10%<ICG R15≤30%、ICG R15>30%）.Concordance analysis of the ICG clearance test parameters was performed using IBM SPSS 27.0 software and plotted using Graph Pad Prism9 software.Results:1、This study found statistically significant differences in ICG R15,EHBF,ICG K,half-life,ACHE,DBIL,and CTP scores between patients who progressed to LF at3 months and those who did not progress to LF（P<0.05）.The single survival analysis suggested that ICG R15,half-life,DBIL,and CTP scores were predictors of progression to LF at 3 months in patients with cirrhosis.The differences between patients who progressed to LF at 6 months and those who did not progress to LF in ICG R15,EHBF,ICG K,half-life,ACHE,TP,ALB,A/G,MO%,RBC,HB,HCT,RDW,Ca²⁺,and CTP scores were statistically significant（P<0.05）.The single factor survival analysis suggested that ICG R15,half-life,MO%,RDW,and CTP score were predictors of progression to LF at 6 months in patients with cirrhosis.2、This study found statistically significant differences between 6-month death and surviving ACLF patients on EHBF,PT,INR,PTR,NE%,NE,PTA,LY%,MELD-Na score,and KCH criteria（P<0.05）.PT,INR,PTR,and NE were suggested to be predictors of 6-month death in ACLF patients by single factor survival analysis.3、In this study,ICG R15 and half-life were found to be positively correlated with AST,ALT,γ-GT,ALP,TBIL,DBIL,IDBIL,TBA,TT,APTT,PT,INR,PTR,MO%,MO,BA,MCV,MCH,MCHC,RDW,MELD,MELD-Na,CTP（P<0.05）,and it was negatively correlated with ACHE,ALB,A/G,PTA,FBG,RBC,Na⁺,Ca²⁺,CO₂CP,and SCr（P<0.05）.EHBF was positively correlated with ACHE,ALB,A/G,PTA,FBG,BA,RBC,Na⁺,Ca²⁺,CO₂CP,SCr（P<0.05）,and negatively correlated with AST,ALT,γ-GT,ALP,TBIL,DBIL,IDBIL,TBA,TT,APTT,PT,INR,PTR,MO%,MO MCV,MCH,MCHC,RDW,MELD,MELD-Na,CTP,and KCH criteria（P<0.05）.4、In this study,it was found that the agreement between our SNT-1000 pigment concentration analyzer and Japanese DDG-3300K pigment concentration analyzer was high for all parameters in the overall group and the three subgroups（the percentages within the consistency limits were≥93%）.Conclusions:1、ICG R15 and half-life may have a predictive value for progression to LF at 3and 6 months in cirrhotic patients.ICG R15 and half-life were elevated in the group of cirrhotic patients progressing to LF and correlated strongly with several laboratory indices,MELD,MELD-Na,and CTP scores;EHBF was decreased in the group of ACLF patients dying at 6 months and correlated strongly with several laboratory indicators,MELD,MELD-Na,CTP,KCH criteria correlated more strongly.2、The parameters measured by the domestic Yatai Zhongke SNT-1000 pigment concentration map analyzer and the parameters measured by the Japanese photoelectric DDG-3300K pigment concentration analyzer maintained high consistency.