Spleen Stiffness Combined With Liver Stiffness Measured by 2D-SWE for the Screening of High-risk Varices in Compensated Advanced Chronic Liver Disease (CHESS2004)

Summary

Variceal hemorrhage is the serious complication in patients with compensated advanced chronic liver disease (cACLD). To evaluate the bleeding risk of varices, esophagogastroduodenoscopy (EGD) should be performed. However, EGD is limited by its invasiveness and uncomfortableness. The Baveno VI criteria recommended that EGD could be spared in patients with liver stiffness (LS) based on transient elastography (TE) \< 20 kPa and platelet count \>150000/mm3. However, only 30% of patients can spare EGD. In order to expand the screening criteria, Expanded-Baveno VI proposed that by using LS (TE)\<25 kPa and platelet count \>110000/mm3, 40% of patients can safely avoid EGD. It is worth noting that the Baveno VI criteria is based on the European and American compensatory cirrhosis cohort (55% for hepatitis C, 14% for non-alcoholic steatohepatitis, 13% for alcoholic hepatitis, 8% for hepatitis B), Expanded-Baveno VI is also of good diagnostic value for hepatitis C, alcoholic, and non-alcoholic steatohepatitis of cACLD. About 257 million people worldwide are infected with hepatitis B virus, and about 80 million people in China alone are infected with hepatitis B virus. Infected with hepatitis B virus is the main etiology of patients with cACLD in china. Hence, Baveno VI and Expanded-Baveno VI may not be suitable for patients with hepatitis B virus-dominant cACLD.

Previous studies have shown that LS has a significant correlation with the severity of portal hypertension. Nevertheless, LS only has a good correlation with portal pressure in the early stage of portal hypertension (hepatic vein pressure gradient ≤10mm Hg), because liver fibrosis is the main cause of portal hypertension in this period. In the late stage of liver cirrhosis, the involvement of hyperdynamic circulation and increased portal blood flow, spleen stiffness (SS) may have a better correlation with HVPG than that of LS. Therefore, SS provides a reliable basis for the hemodynamic changes that occur during the development of liver cirrhosis and avoids the limitations caused by the measurement of LS. Previous study has found that changes in SS before and after non-selective beta-blockers (NSBBs) as primary prophylaxis may be a promising non-invasive tool for predicting hemodynamic response in patients with high-risk varices.

Since SS is much higher than LS, the maximum threshold of 75 kPa measured with TE may not be sufficient to evaluate the hardness of the spleen. Meanwhile, numerous studies have found that the success rate of measuring SS and LS based on 2D-SWE is higher than that of TE. Hence, CHESS2004 study aims to establish a standard for predicting high-risk varices that is more suitable in patients with hepatitis B virus-dominant cACLD. In addition, non-invasive means of SS is used to evaluate the hemodynamic response of patients with high-risk varices receiving prophylaxis NSBBs therapy.

Conditions

• Compensated Advanced Chronic Liver Disease
• Variceal Hemorrhage

Interventions

PROCEDURE

Esophagogasrtoduodendoscopy, spleen stiffness measurement and liver stiffness measurement.

Time frame between elastography measurement and esophagogastroduodendoscopy is within 2 weeks.

Sponsors & Collaborators

• LanZhou University

  collaborator OTHER

• Tianjin Second People's Hospital

  collaborator OTHER

• The Sixth People's Hospital of Shenyang

  collaborator OTHER

• Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region

  collaborator UNKNOWN

• The Central Hospital of Lishui City

  collaborator OTHER

• Guangxi Zhuang Autonomous Region

  collaborator UNKNOWN

• Hepatopancreatobiliary Surgery Institute of Gansu Province

  lead OTHER

Principal Investigators

• Xiaolong Qi, MD · LanZhou University

• Linxue Qian, MD · Beijing Friendship Hospital

• Fengmei Wang, MD · Tianjin Second People's Hospital

• Ye Gu, MD · The Sixth People's Hospital of Shenyang

• Chao Liu, MD · Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region

• Chuxiao Shao, MD · The Central Hospital of Lishui City

• Guo Zhang, MD · Guangxi Zhuang Autonomous Region

• Sumei Ma, MD · LanZhou University

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-08

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• China

Study Locations