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

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ClinicalTrials.gov Identifier: NCT04546360
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborators:
LanZhou University
Tianjin Second People's Hospital
The Sixth People's Hospital of Shenyang
Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region
The Central Hospital of Lishui City
Guangxi Zhuang Autonomous Region
Information provided by (Responsible Party):
Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province

Brief 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.


Condition or disease Intervention/treatment
Compensated Advanced Chronic Liver Disease Variceal Hemorrhage Procedure: Esophagogasrtoduodendoscopy, spleen stiffness measurement and liver stiffness measurement.

Detailed Description:

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. Numerous studies have found that the success rate of measuring SS and LS based on two-dimensional shear wave elastography is higher than that of TE. Hence, CHESS2004 study in seven centers including LanZhou University, Tianjin Second People's Hospital, Sixth People's Hospital of Shenyang, Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region, The Central Hospital of Lishui City and Guangxi Zhuang Autonomous Region, 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Spleen Stiffness Combined With Liver Stiffness Measured by Two-dimensional Shear Wave Elastography for the Screening of High-risk Varices in Patients With Compensated Advanced Chronic Liver Disease (CHESS2004)
Actual Study Start Date : September 8, 2020
Estimated Primary Completion Date : September 7, 2021
Estimated Study Completion Date : September 7, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Overall eligible participants
Eligible participants will receive standard esophagogasrtoduodendoscopy, spleen stiffness measurement and liver stiffness measurement based on two-dimensional shear wave elastography, gallbladder wall thickness, spleen thickness, spleen long diameter and serological examination (platelet count, alanine aminotransferase, aspartate aminotransferase, total bilirubin, creatinine, albumin, prothrombin time, international normalized ratio).
Procedure: Esophagogasrtoduodendoscopy, spleen stiffness measurement and liver stiffness measurement.
Time frame between elastography measurement and esophagogastroduodendoscopy is within 2 weeks.




Primary Outcome Measures :
  1. Accuracy of combined model of spleen stiffness and liver stiffness [ Time Frame: 1 day ]
    To assess the accuracy of combined model of spleen stiffness and liver stiffness to avoid unnecessary esophagogasrtoduodendoscopy in patients with compensated advanced chronic liver disease


Secondary Outcome Measures :
  1. Accuracy of LSPS model base on two-dimensional shear wave elastography [ Time Frame: 1 day ]
    To assess the accuracy of LSPS (liver stiffness-spleen size- to platelet ration risk score) base on two-dimensional shear wave elastography for high-risk varices in patients with compensated advanced chronic liver disease

  2. Rate of hemodynamic responder of patients receiving prophylaxis NSBBs therapy [ Time Frame: 1 month ]
    Rate of hemodynamic responder of patients receiving prophylaxis NSBBs therapy assessed by spleen stiffness



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with compensated advanced chronic liver disease
Criteria

Inclusion Criteria:

  • age 18-75 years;
  • confirmed cirrhosis based on liver biopsy or clinical findings;
  • without decompensated events (e.g. ascites, bleeding, or overt encephalopathy);
  • scheduled to undergo esophagogastroduodenoscopy, spleen stiffness measurement and liver stiffness measurement;
  • estimated survival time>24 months, and model for end-stage liver disease score<19, and without liver transplant;
  • with written informed consent.

Exclusion Criteria:

  • contradictions for esophagogastroduodenoscopy;
  • accepted primary prevention (non-selective beta blockers or endoscopic variceal ligation);
  • time frame between elastography measurement and esophagogastroduodenoscopy>14 days;
  • diagnosed as hepatocellular carcinoma;
  • absence of spleen or splenectomy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04546360


Contacts
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Contact: Xiaolong Qi, MD +8618588602600 ext +8618588602600 qixiaolong@vip.163.com
Contact: Sumei Ma, MD +8615009311518 ext +8615009311518 lzmsm6711@163.com

Locations
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China
Guangxi Zhuang Autonomous Region Not yet recruiting
Guangxi, China
Contact: Guo Zhang         
Lanzhou University Recruiting
Lanzhou, China
Contact: Sumei Ma, MD         
The Central Hospital of Lishui City Not yet recruiting
Lishui, China
Contact: Chuxiao Shao         
Sixth People's Hospital of Shenyang Not yet recruiting
Shenyang, China
Contact: Ye Gu, MD         
Tianjin Second People's Hospital Not yet recruiting
Tianjin, China
Contact: Fengmei Wang, MD         
Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region Not yet recruiting
Xi'zang, China
Contact: Chao Liu, MD         
Sponsors and Collaborators
Hepatopancreatobiliary Surgery Institute of Gansu Province
LanZhou University
Tianjin Second People's Hospital
The Sixth People's Hospital of Shenyang
Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region
The Central Hospital of Lishui City
Guangxi Zhuang Autonomous Region
Investigators
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Study Chair: Xiaolong Qi, MD LanZhou University
Study Chair: Linxue Qian, MD Beijing Friendship Hospital
Principal Investigator: Fengmei Wang, MD Tianjin Second People's Hospital
Principal Investigator: Ye Gu, MD The Sixth People's Hospital of Shenyang
Principal Investigator: Chao Liu, MD Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region
Principal Investigator: Chuxiao Shao, MD The Central Hospital of Lishui City
Principal Investigator: Guo Zhang, MD Guangxi Zhuang Autonomous Region
Principal Investigator: Sumei Ma, MD LanZhou University
Publications:

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Responsible Party: Xiaolong Qi, Chief, Hepatopancreatobiliary Surgery Institute of Gansu Province
ClinicalTrials.gov Identifier: NCT04546360    
Other Study ID Numbers: CHESS2004
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province:
Spleen stiffness
Liver stiffness
Two-dimensional shear wave elastography
High-risk varices
Additional relevant MeSH terms:
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Liver Diseases
Hemorrhage
Pathologic Processes
Digestive System Diseases