Noninvasive Tests to Predict the Presence of Esophageal Varices in Patients With Liver Cirrhosis
Noninvasive Tests to Predict the Presence of Esophageal Varices in Patients With Liver Cirrhosis
Liver cirrhosis is caused by chronic liver diseases, varices exist in 30 - 60% of patients
 with liver cirrhosis. Variceal bleeding is one of the most important complications of
 cirrhosis, accelerating the progression of decompensation to a stage at which the patient is
 at an extremely high risk of death. Endoscopy is the gold standard for the diagnosis of
 varices, However, periodic endoscopic screening in all cirrhotic patients might unnecessarily
 induce an invasive and expensive procedure, ultimately increasing not only the medical
 workload of endoscopy units, but also the financial burden of patients. To avoid unnecessary
 endoscopy in low- risk patients, some simple, non-invasive and accurate tests have been
 developed to identify EVs. Such as Transient elastography (TE) , which is a noninvasive tool
 that measures liver stiffness (LS) correlating to liver fibrosis stage. Moreover, the
 LS-spleen size-to-platelet ratio score (LSPS), which is a combination of three simple
 examination methods (LS, spleen size and platelet count) has been established to accurately
 predict EVs in patients with cirrhosis. Therefore, investigators design this cross-sectional
 study to assess these non-invasive tests in predicting the presence of EVs in patients with
 cirrhosis.
Liver cirrhosis is a result of excessive extracellular matrix deposition in the liver in
 response to chronic inflammatory injury triggered by chronic liver diseases. And Cirrhosis is
 classified in 2 distinct clinical stages, compensated (Currently, both terms : "compensated
 advanced chronic liver disease(cACLD)" and "compensated cirrhosis" are acceptable) and
 decompensated, defined by the presence or absence of overt clinical complications of
 cirrhosis (ascites, variceal hemorrhage, hepatic encephalopathy). Portal hypertension is a
 frequent complication of liver cirrhosis, a contributing fator for ascites and hepatic
 encephalopathy, and a direct cause of variceal hemorrhage. An increase in portal pressure
 leads to the development of portosystemic collateral circulation, of which varices are the
 most important clinical feature. In accordance with the Baveno II consensus conference,
 esophageal varices (EVs) were classified as absent, small (diameter < 5 mm) or large
 (diameter ≥ 5 mm). The presence of red wale marks on the variceal wall in EVs was also
 recorded. EVs at a high risk for bleeding were defined according to the Baveno V criteria as
 large EVs or small EVs with red signs or EVs in patients with Child-Pugh class C disease.
 varices exist in 30 - 60% of patients with liver cirrhosis, depending on the severity of
 Portal hypertension. The yearly rate of development of new cases is 5 - 10% , whereas the
 growth rate from small to large varices ranges between 5 and 30 %.

 Variceal bleeding is the most important and the most lethal complication of cirrhosis,
 accelerating the progression of decompensation to a stage at which the patient is at an
 extremely high risk of death. Therefore, the diagnosis, prevention, and management of EVs are
 important for patients with cirrhosis. And screening for EVs in all patients with cirrhosis
 is also strongly recommended across guidelines and consensus statements. Endoscopy is the
 gold standard for the diagnosis of varices, and is recommended as the screening method to
 identify those who should undergo prophylactic treatment when the diagnosis of cirrhosis is
 made. Nonselective β-blockers significantly reduce the bleeding rate in more than half of
 patients with high-risk EVs (HEVs). However, as the prevalence of HEVs at any given point in
 time is 15 - 25%, the majority of subjects undergoing screening endoscopy either do not have
 varices, or have varices that do not require prophylactic therapy. Therefore, periodic
 endoscopic screening in all cirrhotic patients, especially low-risk groups, might
 unnecessarily induce an invasive and expensive procedure, ultimately increasing not only the
 medical workload of endoscopy units, but also the financial burden to patients, as the number
 of patients with chronic liver disease increases and their survival improves. Furthermore,
 compliance may be limited, because even asymptomatic patients may be required to repeatedly
 undergo an unpleasant endoscopic procedure, which usually requires conscious sedation
 decreasing work productivity, It also carries rare but serious complications. Patients might
 be reluctant to receive endoscopy and become discouraged in starting preventive measures. All
 of these reasons lead to decline in patient compliance with treatment and follow-ups.
 Meanwhile, the endoscopy-related complications reported by a related article is close to 0.1%
 of incidence.

 To avoid unnecessary endoscopy in low-risk patients, some simple, non-invasive and accurate
 tests have been developed to identify EVs. Transient elastography (TE) is a noninvasive tool
 that measures liver stiffness (LS) correlating to liver fibrosis stage. While LS also shows
 potential in the prediction of EVs, its role is still under debate. Moreover, the LS-spleen
 size-to-platelet ratio score (LSPS), which is a combination of three simple examination
 methods (LS, spleen size and platelet count) has been established to accurately predict EVs
 in patients with cirrhosis. And recent Baveno VI recommended the combination of transient
 elastography and platelet count for ruling out HEVs in patients with chronic liver disease.

 Although there is a correlation between these non-invasive tools and the presence of EVS or
 HEVs, the optimal cut-offs and their validities vary in the different studies with different
 etiologies. In addition, the qualities of EVs assessment have not been provided in these
 studies. Therefore, investigators design this cross-sectional study to assess these
 non-invasive tests in predicting the presence of EVs in patients with cirrhosis. This could
 prevent unnecessary endoscopy with related complications and costs. And the results of
 noninvasive tests will be compared with endoscopy (ie, the gold standard for diagnosing EVs).
Inclusion Criteria:

 1. Aged 18 - 80 years old;

 2. Diagnosis of liver cirrhosis (Cirrhosis is diagnosed using standard laboratory,
 radiological, and physical examination findings, or by liver histology in equivocal
 cases);

 3. Paired noninvasive tests (blood tests, TE, abdominal CT, and/or ultrasound) and
 endoscopy within 3 months;

 Exclusion Criteria:

 1. A body mass index > 35;

 2. Severe cardiopulmonary diseases, renal failure，acute illness; infectious diseases;

 3. Pregnant or breast-feeding subjects;

 4. Previous splenectomy or liver transplantation;(文献55)

 5. Previous β-blocker therapy;

 6. Endoscopic treatments (band ligation or sclerotherapy);

 7. Previous surgery for portal hypertension or transjugular intrahepatic portosystemic
 stent shunt placement;

 8. Portal vein or splenic vein thrombosis;

 9. Current or past history of hepatocellular carcinoma;

 10. Presence of severe ascites that might significantly hamper the accurate assessment of
 LSM;

 11. Unreliable LSM with an interquartile range (IQR) to median value ratio (IQR/M) of >
 0.3, a success rate of < 60% , or validated measurements of < 10;