An observational study in Portal Hypertension, sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province · Observational
How to construct a novel, non-invasive, accurate, and convenient method to achieve prediction of hepatic venous pressure gradient (HVPG) is an important general problem in the management of portal hypertension in cirrhosis. We plan to investigate the ability of AI analysis of Ultrasound, computed tomography (CT) or magnetic resonance (MR) to establish a risk stratification system and perform tailored management for portal hypertension in cirrhosis.
China suffers the heaviest burden of liver disease in the world. The number of chronic liver disease is more than 400 million. Either viral-related hepatitis, alcoholic hepatitis, or metabolic-related fatty hepatitis, etc. may progress to cirrhosis, which greatly threatens public health. Portal hypertension is a critical risk factor that correlates with clinical prognosis of patients with cirrhosis. According to the Consensus on clinical application of hepatic venous pressure gradient in China (2018), hepatic venous pressure gradient (HVPG) greater than 10,12,16,20 mmHg correspondingly predicts different outcomes of patients with cirrhosis portal hypertension. It is of great significance to establish a risk stratification system and perform tailored management for portal hypertension in cirrhosis. As a universal gold standard for diagnosing and monitoring portal hypertension, HVPG remains limitation for clinical application due to its invasiveness. How to construct a novel, non-invasive, accurate, and convenient method to achieve prediction of HVPG is an important general problem in the management of portal hypertension in cirrhosis.
The development of radiomics technique provides an approach to solve abovementioned clinical issues. Based on artificial intelligence algorithms, radiomics harnesses mineable, high-resolution, and quantitative features from encrypted medical images, along with clinical or genetic data to produce evidence-based decision support system, to achieve the clinical targets including diagnosis, treatment effect evaluation, and prognosis prediction. In this project, aiming at development of a risk stratification system for hypertension management in cirrhosis, we will construct a standard-of-care database and utilize radiomics tool to construct the decision making system. We will take responsibility for achievement of organ and vessel segmentation, radiomic feature selection, and signature construction for prediction of hypertension classification, and accomplish the development of prototype system which would integrate four modules including database management, HVPG risk stratification application module, predicted outcome presentation module, and prognostic information curation module. This project will focus on two aspects which are correspondingly machine learning algorithms optimization and prototype system development, so as to promote the precision medicine in liver disease.
375 studies on the registry are indexed under Hypertension, Portal; 114 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 150 across 135 observational studies indexed under Hypertension, Portal.
Browse Hypertension, Portal studies →Hepatopancreatobiliary Surgery Institute of Gansu Province is the lead sponsor of 44 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Organize paticipating units to collect standard-of-care data including radiological and clinical data. Patients diagnosed with cirrhosis who received HVPG measurement and enhanced abdominal ultrasound/CT/MRI scan should be enrolled.
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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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Training cohort was set to develop the novel non-invasive model for virtual HVPG
Diagnostic Test: CT · Diagnostic Test: MRI · Diagnostic Test: HVPG · Diagnostic Test: Ultrasound
Validation cohort was set to validate the novel non-invasive model for virtual HVPG in different people in same environments
Diagnostic Test: CT · Diagnostic Test: MRI · Diagnostic Test: HVPG · Diagnostic Test: Ultrasound
Test cohort was set to test the novel non-invasive model for virtual HVPG in different environments
Diagnostic Test: CT · Diagnostic Test: MRI · Diagnostic Test: HVPG · Diagnostic Test: Ultrasound
enhanced CT with standard procedure
enhanced MRI with standard procedure
HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures
Digestive ultrasound with standard procedure
Diagnostic value
Accuracy of the novel model for virtual HVPG
Time frame: 24 months
No study locations are listed for this record.
Plan to share: No
Start is estimated for Dec 2023; primary completion for Dec 2025, 23 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Hepatopancreatobiliary Surgery Institute of Gansu Province