A Novel Imaging Based Quantitative Model-aided Detection of Portal Hypertension in Patients With Cirrhosis (CHESS2104)

NCT ID: NCT05068492

Last Updated: 2023-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-10

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Portal Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Training cohort

Training cohort was set to develop the novel non-invasive model for virtual HVPG

CT

Intervention Type DIAGNOSTIC_TEST

enhanced CT with standard procedure

MRI

Intervention Type DIAGNOSTIC_TEST

enhanced MRI with standard procedure

HVPG

Intervention Type DIAGNOSTIC_TEST

HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Digestive ultrasound with standard procedure

Validation cohort

Validation cohort was set to validate the novel non-invasive model for virtual HVPG in different people in same environments

CT

Intervention Type DIAGNOSTIC_TEST

enhanced CT with standard procedure

MRI

Intervention Type DIAGNOSTIC_TEST

enhanced MRI with standard procedure

HVPG

Intervention Type DIAGNOSTIC_TEST

HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Digestive ultrasound with standard procedure

Test cohort

Test cohort was set to test the novel non-invasive model for virtual HVPG in different environments

CT

Intervention Type DIAGNOSTIC_TEST

enhanced CT with standard procedure

MRI

Intervention Type DIAGNOSTIC_TEST

enhanced MRI with standard procedure

HVPG

Intervention Type DIAGNOSTIC_TEST

HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Digestive ultrasound with standard procedure

Interventions

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CT

enhanced CT with standard procedure

Intervention Type DIAGNOSTIC_TEST

MRI

enhanced MRI with standard procedure

Intervention Type DIAGNOSTIC_TEST

HVPG

HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures

Intervention Type DIAGNOSTIC_TEST

Ultrasound

Digestive ultrasound with standard procedure

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. any previous liver or spleen surgery;
2. liver cancer; chronic acute liver failure;
3. acute portal hypertension;
4. unreliable HVPG or ultrasound/CT/MRI results due to technical reasons.
5. with liver interventional therapy between HVPG and ultrasound/CT/MRI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Portal Hypertension Alliance in China

UNKNOWN

Sponsor Role collaborator

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role lead

Responsible Party

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Xiaolong Qi

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaolong Qi, Prof.

Role: PRINCIPAL_INVESTIGATOR

CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China

Central Contacts

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Yifei Huang

Role: CONTACT

15800004518

References

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Liu Y, Ning Z, Ormeci N, An W, Yu Q, Han K, Huang Y, Liu D, Liu F, Li Z, Ding H, Luo H, Zuo C, Liu C, Wang J, Zhang C, Ji J, Wang W, Wang Z, Wang W, Yuan M, Li L, Zhao Z, Wang G, Li M, Liu Q, Lei J, Liu C, Tang T, Akcalar S, Celebioglu E, Ustuner E, Bilgic S, Ellik Z, Asiller OO, Liu Z, Teng G, Chen Y, Hou J, Li X, He X, Dong J, Tian J, Liang P, Ju S, Zhang Y, Qi X. Deep Convolutional Neural Network-Aided Detection of Portal Hypertension in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2020 Dec;18(13):2998-3007.e5. doi: 10.1016/j.cgh.2020.03.034. Epub 2020 Mar 21.

Reference Type BACKGROUND
PMID: 32205218 (View on PubMed)

Liu F, Ning Z, Liu Y, Liu D, Tian J, Luo H, An W, Huang Y, Zou J, Liu C, Liu C, Wang L, Liu Z, Qi R, Zuo C, Zhang Q, Wang J, Zhao D, Duan Y, Peng B, Qi X, Zhang Y, Yang Y, Hou J, Dong J, Li Z, Ding H, Zhang Y, Qi X. Development and validation of a radiomics signature for clinically significant portal hypertension in cirrhosis (CHESS1701): a prospective multicenter study. EBioMedicine. 2018 Oct;36:151-158. doi: 10.1016/j.ebiom.2018.09.023. Epub 2018 Sep 27.

Reference Type BACKGROUND
PMID: 30268833 (View on PubMed)

Other Identifiers

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CHESS2104

Identifier Type: -

Identifier Source: org_study_id

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