Ignite Creation Date:
2024-05-06 @ 6:07 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05551884
Status:
RECRUITING
Last Update Posted:
2023-04-25
First Post:
2022-09-20
Brief Title:
Non-invasive Diagnosis of Portal Hypertension in Cirrhosis Based on Metabolomics Technology
Sponsor:
Hepatopancreatobiliary Surgery Institute of Gansu Province
Organization:
Hepatopancreatobiliary Surgery Institute of Gansu Province
Study Overview
Official Title:
Non-invasive Diagnosis of Portal Hypertension in Cirrhosis Based on Metabolomics TechnologyCHESS2207 a Prospective Multicenter Study
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Portal hypertension PH is a group of syndromes characterized by abnormal changes in the portal blood flow system mostly caused by cirrhosis It is an important factor affecting the clinical prognosis of cirrhotic patients and its severity determines the occurrence and development of cirrhotic complications
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 35 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-TOFMS and UPLC-QTOFMS 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
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 35 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-TOFMS and UPLC-QTOFMS 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
Detailed Description:
Portal hypertension PH is a group of syndromes characterized by abnormal changes in the portal blood flow system mostly caused by cirrhosis It is an important factor affecting the clinical prognosis of cirrhotic patients and its severity determines the occurrence and development of cirrhotic complications
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 35 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 Bucks 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-TOFMS and UPLC-QTOFMS 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
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 35 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 Bucks 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-TOFMS and UPLC-QTOFMS 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None