An observational study in Liver Fibrosis, Cirrhosis and Portal Hypertension, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-10.
Sponsored by Shanghai Zhongshan Hospital · Observational
This study is to establish a noninvasive diagnostic platform based on hemodynamic information for the assessment of liver fibrosis, liver cirrhosis and portal hypertension.
As the hemodynamics of liver vessels depend on the liver tissue mechanics, we hypothesize that the hemodynamics measurements of the liver are strongly correlated with the stages of liver fibrosis and portal hypertension, and can therefore serve as an alternative means of diagnosis. We have developed a physics-based mathematical model that incorporates our biological understanding of fibrosis development. The model quantitatively predicts changes of liver tissue stiffness and blood flow dynamics as a function of fibrosis stage. Preliminary data using ultrasound Doppler images and needle biopsy from liver fibrosis patients have suggested the 'prove of principle. We propose further test our hypothesis by collecting and analyzing ultrasound Doppler and biopsy data to confirm the correlation between blood flow dynamics and disease stage from patients with hepatic fibrosis and portal hypertension. If tested true, we can expect to use features of ultrasound Doppler as a non-invasive means of diagnosis for fibrosis and portal hypertension.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's planned enrollment of 200 is above the median of 171 across 526 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Shanghai Zhongshan Hospital is the lead sponsor of 652 studies on the registry; 291 are open to participants now.
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Inpatients who undergo liver biopsy or hepatic venous pressure gradient test in Zhongshan hospital Fudan University
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
liver biopsy proved
Diagnostic Test: hemodynamics tests
hepatic venous pressure gradient (HVPG) proved
Diagnostic Test: hemodynamics tests
Hemodynamics tests for intrahepatic blood flow by colour doppler ultrasound
Sensitivity
Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
Time frame: baseline
Specificity
Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
Time frame: baseline
Positive predictive value (PPV)
Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
Time frame: baseline
Negative predictive value (NPV)
Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
Time frame: baseline
Area under ROC curve (AUROC)
Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
Time frame: baseline
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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