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

NCT05068492 | Unknown

• 1 other identifier: CHESS2104
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Portal Hypertension

Keywords

Cirrhosis; Portal hypertension; Artificial intelligence; CT; MRI; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Diagnostic value

  Accuracy of the novel model for virtual HVPG

  24 months

Study Arms (3)

Training cohort

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

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

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

Interventions

CT DIAGNOSTIC_TEST

enhanced CT with standard procedure

Test cohort; Training cohort; Validation cohort

MRI DIAGNOSTIC_TEST

enhanced MRI with standard procedure

Test cohort; Training cohort; Validation cohort

HVPG DIAGNOSTIC_TEST

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

Test cohort; Training cohort; Validation cohort

Ultrasound DIAGNOSTIC_TEST

Digestive ultrasound with standard procedure

Test cohort; Training cohort; Validation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead
• Portal Hypertension Alliance in China: collaborator

Related Publications (2)

• 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.

  PMID: 32205218 BACKGROUND

• 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.

  PMID: 30268833 BACKGROUND

MeSH Terms

Conditions

Hypertension, Portal; Fibrosis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Xiaolong Qi, Prof.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifei Huang

CONTACT

15800004518; huangyf1995@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Institute of Portal Hypertension, The First Hospital of Lanzhou University

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 5, 2021
• Study Start: December 10, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share