Non-invasive Diagnosis of Portal Hypertension in Cirrhosis Based on Metabolomics Technology
NCT ID: NCT05551884
Last Updated: 2023-04-25
Study Results
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Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2023-02-15
2023-09-14
Brief Summary
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Clinically, measurement of portal venous pressure directly is highly invasive, and factors such as intra-abdominal pressure changes can interfere with the results, limiting its clinical application. Hepatic venous pressure gradient (HVPG) is the gold standard for assessing PH in cirrhosis. The normal range of HVPG is 3\~5 mmHg, and HVPG ≥5 mmHg indicates the presence of PH. AASLD stated that HVPG ≥10 mmHg is defined as clinically significant portal hypertension (CSPH), and the risk of decompensation events is significantly increased at this stage. However, HVPG is an invasive test, which is unacceptable to some patients, such as being expensive, difficult to repeat, and poor patient compliance.
Non-invasive tests for PH include serological tests, anatomical imaging and combination models. Imaging evidence of portal collateral circulation or hepatic blood flow in the portal venous system based on ultrasound Doppler, CT or magnetic resonance imaging techniques can assist to diagnose PH. In addition, elastography techniques such as transient elastography, point shear wave elastography, two-dimensional shear wave elastography and magnetic resonance elastography can be used to measure liver stiffness and spleen stiffness to assess PH. Some biochemical markers are also considered as non-invasive tests for PH. However, the available biomarkers are not yet a substitute for the HVPG accurately, and therefore, there is an urgent need for the development of biomarkers associated with HVPG in clinical practice.
Metabolomics is a method to analyze the concentrated changes of endogenous small molecule metabolites under the combined effect of genetic, biological and environmental factors with the help of various high-throughput technologies. Metabolites are at the end of the biological information flow, and their changes are the ultimate expression of the information from the coordinated action of each group, objectively reflecting the overall changes of the organism. Currently, metabolomics techniques have been widely used in screening biomarkers of liver diseases. Wang et al. applied GC-TOF/MS and UPLC-QTOF/MS to study the urinary metabolomics of patients with hepatitis B cirrhosis and showed that α-hydroxymaurolate, tyrosine-betaine, 3-hydroxyisovaleric acid, knife-serine succinate, estrone and GUDCA were significantly altered in different Child-Pugh grades of cirrhosis, suggesting that these metabolites are potential biomarkers to identify different pathological stages of cirrhosis. Therefore, metabolomics is a reliable and valid tool for biomarker discovery.
In conclusion, this study analyzed significantly altered metabolites in patients with hepatitis B cirrhosis using metabolomics to explore potential differential metabolites that are highly correlated with HVPG. Further, serological biomarkers were identified as an alternative to HVPG testing through model construction and validation.
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Detailed Description
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Clinically, measurement of portal venous pressure directly is highly invasive, and factors such as intra-abdominal pressure changes can interfere with the results, limiting its clinical application. Hepatic venous pressure gradient (HVPG) is the gold standard for assessing PH in cirrhosis. The normal range of HVPG is 3\~5 mmHg, and HVPG ≥5 mmHg indicates the presence of PH. AASLD stated that HVPG ≥10 mmHg is defined as clinically significant portal hypertension (CSPH), and the risk of decompensation events is significantly increased at this stage. However, HVPG is an invasive test, which is unacceptable to some patients, such as being expensive, difficult to repeat, and poor patient compliance.
Non-invasive tests for PH include serological tests, anatomical imaging and combination models. Imaging evidence of portal collateral circulation or hepatic blood flow in the portal venous system based on ultrasound Doppler, CT or magnetic resonance imaging techniques can assist to diagnose PH. In addition, elastography techniques such as transient elastography, point shear wave elastography, two-dimensional shear wave elastography and magnetic resonance elastography can be used to measure liver stiffness and spleen stiffness to assess PH. Some biochemical markers are also considered as non-invasive tests for PH. A study by Buck's team showed that serum inflammatory markers in cirrhotic patients were highly correlated with HVPG. Liver fibrosis index has been proposed for the grading and identification of fibrosis with moderate accuracy. Bone bridging protein levels were also correlated with the degree of liver fibrosis and CSPH. Overall, non-invasive serological markers have great potential in assessing PH. However, the available biomarkers are not yet a substitute for the HVPG accurately, and therefore, there is an urgent need for the development of biomarkers associated with HVPG in clinical practice.
Metabolomics is a method to analyze the concentrated changes of endogenous small molecule metabolites under the combined effect of genetic, biological and environmental factors with the help of various high-throughput technologies. Metabolites are at the end of the biological information flow, and their changes are the ultimate expression of the information from the coordinated action of each group, objectively reflecting the overall changes of the organism. Currently, metabolomics techniques have been widely used in screening biomarkers of liver diseases. Wang et al. applied GC-TOF/MS and UPLC-QTOF/MS to study the urinary metabolomics of patients with hepatitis B cirrhosis and showed that α-hydroxymaurolate, tyrosine-betaine, 3-hydroxyisovaleric acid, knife-serine succinate, estrone and GUDCA were significantly altered in different Child-Pugh grades of cirrhosis, suggesting that these metabolites are potential biomarkers to identify different pathological stages of cirrhosis. Therefore, metabolomics is a reliable and valid tool for biomarker discovery.
In conclusion, this study analyzed significantly altered metabolites in patients with hepatitis B cirrhosis using metabolomics to explore potential differential metabolites that are highly correlated with HVPG. Further, serological biomarkers were identified as an alternative to HVPG testing through model construction and validation.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Training cohort
Training cohort was set to develop the novel non-invasive model based on metabolomics technology for HVPG.
Metabolites and HVPG
HVPG measurement are performed by well-trained interventional radiologists in accordance with standard operating procedures.
All enrolled patients were analyzed for potential differential metabolites using metabolomics.
Validation cohort
Validation cohort was set to validate the novel non-invasive model based on metabolomics technology for HVPG.
Metabolites and HVPG
HVPG measurement are performed by well-trained interventional radiologists in accordance with standard operating procedures.
All enrolled patients were analyzed for potential differential metabolites using metabolomics.
Interventions
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Metabolites and HVPG
HVPG measurement are performed by well-trained interventional radiologists in accordance with standard operating procedures.
All enrolled patients were analyzed for potential differential metabolites using metabolomics.
Eligibility Criteria
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Inclusion Criteria
2. Control group: no liver-related diseases, matched with the case group in terms of race, age, sex, and BMI.
Exclusion Criteria
2. Patients with severe liver failure, hepatocellular carcinoma, portal vein thrombosis.
3. Patients with recent blood transfusion due to bleeding.
4. Patients who are pregnant or lactating.
5. Patients with endocrine and metabolic diseases such as diabetes mellitus.
6. Patients treated with anticoagulants, or using drugs that may affect visceral hemodynamics or portal pressure within the last 2 weeks.
7. Severe coagulation dysfunction, international normalized ratio \> 5.
8. Those who are unable to lie flat or cannot tolerate the procedure.
18 Years
75 Years
ALL
No
Sponsors
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The Third People's Hospital of Taiyuan
OTHER
Lishui Country People's Hospital
OTHER
Shenyang Sixth People's Hospital
OTHER
QuFu People's Hospital
INDIV
Shulan (Hangzhou) Hospital
OTHER
Hepatopancreatobiliary Surgery Institute of Gansu Province
OTHER
Responsible Party
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Xiaolong Qi
Prof.
Principal Investigators
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Xiaolong Qi, M.D.
Role: STUDY_CHAIR
Portal Hypertension Alliance in China
Ying Guo, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Third People's Hospital of Taiyuan
Jiaojian Lv, M.D.
Role: PRINCIPAL_INVESTIGATOR
Lishui Country People's Hospital
Yang Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shenyang Sixth People's Hospital
Shirong Liu, M.D.
Role: PRINCIPAL_INVESTIGATOR
QuFu People's Hospital
Huadong Yan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shulan (Hangzhou) Hospital
Locations
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The Third People's Hospital of Taiyuan
Taiyuan, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Ying Guo, M.D.
Role: primary
References
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Wang X, Lin SX, Tao J, Wei XQ, Liu YT, Chen YM, Wu B. Study of liver cirrhosis over ten consecutive years in Southern China. World J Gastroenterol. 2014 Oct 7;20(37):13546-55. doi: 10.3748/wjg.v20.i37.13546.
Groszmann RJ, Wongcharatrawee S. The hepatic venous pressure gradient: anything worth doing should be done right. Hepatology. 2004 Feb;39(2):280-2. doi: 10.1002/hep.20062. No abstract available.
Abraldes JG, Sarlieve P, Tandon P. Measurement of portal pressure. Clin Liver Dis. 2014 Nov;18(4):779-92. doi: 10.1016/j.cld.2014.07.002. Epub 2014 Aug 21.
de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.
Zhang CE, Niu M, Li Q, Zhao YL, Ma ZJ, Xiong Y, Dong XP, Li RY, Feng WW, Dong Q, Ma X, Zhu Y, Zou ZS, Cao JL, Wang JB, Xiao XH. Urine metabolomics study on the liver injury in rats induced by raw and processed Polygonum multiflorum integrated with pattern recognition and pathways analysis. J Ethnopharmacol. 2016 Dec 24;194:299-306. doi: 10.1016/j.jep.2016.09.011. Epub 2016 Sep 9.
Wang X, Wang X, Xie G, Zhou M, Yu H, Lin Y, Du G, Luo G, Jia W, Liu P. Urinary metabolite variation is associated with pathological progression of the post-hepatitis B cirrhosis patients. J Proteome Res. 2012 Jul 6;11(7):3838-47. doi: 10.1021/pr300337s. Epub 2012 Jun 7.
Other Identifiers
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CHESS2207
Identifier Type: -
Identifier Source: org_study_id
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