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A study on non-invasive assessment of portal hypertension and its prognosis based on fluid dynamics analysis and 4D flow-MR technology

A study on non-invasive assessment of portal hypertension and its prognosis based on fluid dynamics analysis and 4D flow-MR technology

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118580
Enrollment
Unknown
Registered
2026-02-09
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Portal Hypertension, Liver Cirrhosis

Interventions

MPH Patient Group (Part One):None
Healthy Control Group (Part One:None
CSPH patient Group (Part Two):None
MPH Patient Group (Part Two):None

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Part 1: Early Prediction of Mild Portal Hypertension (MPH) 1. Case Group - MPH Patients (1) Age >= 18 years; (2) Pathologically diagnosed with cirrhosis and confirmed as MPH by HVPG measurement (5 mm Hg = 18 years; (2) No history of cirrhosis and HVPG = 18 years; (2) Pathologically diagnosed with cirrhosis and confirmed as CSPH by HVPG measurement (HVPG >= 10 mmHg); (3) Planned to undergo contrast-enhanced upper abdominal MRI and 4D-flow MRI. 2. Control Group - MPH Patients (1) Age >= 18 years; (2) Pathologically diagnosed with cirrhosis and confirmed as MPH by HVPG measurement (5 mm Hg <= HVPG <= 10 mmHg); (3) Planned to undergo contrast-enhanced upper abdominal MRI and 4D-flow MRI.

Exclusion criteria

Exclusion criteria: Part 1: Early Prediction of Mild Portal Hypertension (MPH) Case Group - MPH Patients 1. Coexisting pathologically confirmed liver-related neoplastic lesions, such as hepatocellular carcinoma or cholangiocarcinoma; 2. Contraindications to MRI preventing upper abdominal contrast-enhanced MRI; 3. Poor MR image quality rendering data analysis impossible; 4. Pathologically confirmed other malignancies; 5. Other conditions deemed ineligible by the investigator. Part 2: Risk Stratification and Prognostic Assessment of Clinically Significant Portal Hypertension (CSPH) Case Group - CSPH Patients 1. Coexisting pathologically confirmed liver-related neoplastic lesions, such as hepatocellular carcinoma or cholangiocarcinoma; 2. Contraindications to MRI preventing upper abdominal contrast-enhanced MRI; 3. Poor MR image quality rendering data analysis impossible; 4. Pathologically confirmed other malignancies; 5. Other conditions deemed ineligible by the investigator.

Design outcomes

Primary

MeasureTime frame
Hemodynamic parameters of the portal venous system (including turbulent kinetic energy, TKE, and pressure difference, PD);

Secondary

MeasureTime frame
HVPG level grouping (>=12 mmHg, >=16 mmHg, >=20 mmHg);Clinical endpoint events (refractory ascites, bleeding, recurrent bleeding, failed bleeding control, death, progression-free survival [PFS], and overall survival [OS]);Area under the ROC curve (AUC), sensitivity, specificity, and accuracy;Intraclass correlation coefficient (ICC);

Countries

China

Contacts

Public ContactWan Shang

West China Hospital, Sichuan University

shang.w.gracy@wchscu.cn+86 132 8110 0309

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026