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临床试验/NCT05068492
NCT05068492尚未招募不适用

A Novel Imaging Based Quantitative Model-aided Detection of Portal Hypertension in Patients With Cirrhosis (CHESS2104): A Prospective, Multicenter Study

Hepatopancreatobiliary Surgery Institute of Gansu Province0 个研究点目标入组 2,000 人开始时间: 2023年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
2,000
主要终点
Diagnostic value

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 18 years old;
  • confirmed cirrhosis (laboratory, imaging and clinical symptoms);
  • with ultrasound/CT/MRI within 1 month prior to HVPG measurement;
  • written informed consent.

排除标准

  • any previous liver or spleen surgery;
  • liver cancer; chronic acute liver failure;
  • acute portal hypertension;
  • unreliable HVPG or ultrasound/CT/MRI results due to technical reasons.
  • with liver interventional therapy between HVPG and ultrasound/CT/MRI

结局指标

主要结局

Diagnostic value

时间窗: 24 months

Accuracy of the novel model for virtual HVPG

次要结局

未报告次要终点

研究者

发起方
Hepatopancreatobiliary Surgery Institute of Gansu Province
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaolong Qi

Chief, Institute of Portal Hypertension, The First Hospital of Lanzhou University

Hepatopancreatobiliary Surgery Institute of Gansu Province

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