Predicting Outcomes and Risk of Complications Related to Portal hyperTension by Non-invasive Assessment of Liver Flow With 4D MRI
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Correlation between invasive hepatic venous pressure gradient (HVPG) and quantitative hepatic 4D-flow MRI hemodynamic parameters
研究概览
简要总结
PORTAL-4D is a prospective, interventional, non-randomized, parallel-group diagnostic study conducted at Pitié-Salpêtrière Hospital (Paris, France).
Portal hypertension is the main driver of hepatic decompensation and is associated with ascites, variceal bleeding, hepatic encephalopathy, and reduced survival. The current gold standard for assessing portal hypertension is the invasive hepatic venous pressure gradient (HVPG) measurement performed via the transjugular route. However, HVPG is invasive, operator-dependent, and limited to specialized centers. A reliable non-invasive alternative is therefore highly needed.
60 adults patients with cirrhosis will be enrolled and divided into two parallel groups: MASLD group (n=24): Patients with compensated cirrhosis related to metabolic dysfunction-associated steatotic liver disease (MASLD).
TIPS group (n=36): Patients with decompensated cirrhosis referred for transjugular intrahepatic portosystemic shunt (TIPS) placement.
The primary objective is to assess the correlation between invasive HVPG values and 4D-flow MRI parameters. Secondary objectives include evaluating the prognostic value of 4D-flow MRI in predicting portal hypertension-related complications and post-TIPS outcomes within 6 months.
The study is expected to validate 4D-flow MRI as an non-invasive diagnostic and prognostic tool for portal hypertension, potentially improving patient selection for TIPS and reducing reliance on invasive procedures.
详细描述
Portal hypertension is the main determinant of hepatic decompensation in cirrhotic patients and is associated with major complications such as variceal gastrointestinal bleeding, refractory ascites, hepatic encephalopathy, and liver-related mortality. The reference standard for assessing clinically significant portal hypertension is the invasive hepatic venous pressure gradient (HVPG), measured via the transjugular route. HVPG reflects the hemodynamic consequences of increased intrahepatic resistance and portal inflow and has strong prognostic value. An HVPG ≥10 mmHg defines clinically significant portal hypertension and is associated with a higher risk of decompensation and mortality. In patients treated with TIPS, achieving a post-procedural gradient <12 mmHg or a reduction of at least 50% from baseline is associated with a decreased risk of rebleeding and other complications.
Despite its clinical relevance, HVPG measurement is invasive, requires specialized expertise, and is not widely available. Moreover, it may not capture the full complexity of portal and systemic hemodynamics. Consequently, there is a critical unmet need for non-invasive, reproducible, and operator-independent techniques capable of assessing portal hypertension and guiding clinical decision-making.
4D-flow MRI is an advanced imaging technique that enables time-resolved, three-dimensional quantification of blood flow in multiple vascular territories within a single acquisition. In the hepatic and splanchnic circulation, it allows comprehensive measurement of portal vein, splenic vein, superior mesenteric vein, hepatic veins, and inferior vena cava flow, including velocities, flow volumes, and shunt fractions. Preliminary studies have demonstrated the feasibility and reproducibility of 4D-flow MRI in evaluating portal hemodynamics, but robust validation against invasive HVPG and prospective prognostic evaluation remain limited.
The study will enroll 60 adult patients with confirmed cirrhosis, divided into two parallel groups:
MASLD Group (n=24) participants will undergo transjugular HVPG measurement (performed specifically for research purposes), hepatic 4D-flow MRI with gadolinium contrast, and standardized blood sampling. They will be followed for 6 months to evaluate the occurrence of portal hypertension-related events, including ascites requiring intervention, variceal bleeding, hepatic encephalopathy, and liver-related death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Applicable to both groups :
- •Age ≥ 18 years
- •Eligible to undergo MRI examination
- •Prior clinical evaluation completed
- •Covered by a national health insurance scheme or beneficiary thereof (excluding State Medical Aid AME)
- •Patient informed and written informed consent obtained
- •Specific to the MASLD group :
- •Indication for TIPS validated during a multidisciplinary team meeting and documented in the patient's medical record, including one of the following:
- •Refractory ascites
- •Hepatic hydrothorax
- •Failure of secondary prophylaxis of variceal gastrointestinal bleeding
- •Preemptive TIPS
- •Preoperative TIPS
- •Specific to the MASLD group :
- •Past or current exposure to metabolic risk factors (overweight, obesity, type 2 diabetes mellitus, arterial hypertension, dyslipidemia)
- •Liver stiffness > 15 kPa measured by transient elastography
- •Liver biopsy documenting steatosis with stage 3 fibrosis or cirrhosis
- •Alcohol consumption < 20 g/day for women and < 30 g/day for men, assessed using validated routine clinical questionnaires
排除标准
- •Applicable to both groups :
- •Any contraindication to MRI (cardiac pacemaker, implantable cardioverter-defibrillator, cochlear implants, intraocular metallic foreign bodies, intracranial vascular clips).
- •Prior liver transplantation.
- •Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception.
- •Individual under legal guardianship or trusteeship, or unable to provide informed consent.
- •Participation in another interventional clinical study or currently within the exclusion period following a previous ongoing study.
- •Specific to the TIPS group
- •Patients undergoing salvage TIPS placement in the setting of hemorrhagic shock. Specific to the MASLD group
- •Other etiologies of chronic liver disease, including viral hepatitis, autoimmune liver disease, or hemochromatosis
研究组 & 干预措施
TIPS group
TIPS group : Adults with decompensated cirrhosis referred for transjugular intrahepatic portosystemic shunt (TIPS). Participants undergo 4D-flow liver MRI before and after TIPS placement, invasive pressure measurements, blood sampling, and 6-month follow-up to assess post-TIPS outcomes.
干预措施: Samples Without DNA (Biological)
MASLD group
MASLD group : Adults with compensated cirrhosis related to metabolic dysfunction-associated steatotic liver disease (MASLD). Participants undergo invasive HVPG measurement and 4D-flow liver MRI, with 6-month follow-up to assess portal hypertension-related complications and prognostic value of imaging parameters.
干预措施: 4D-Flow Liver and heart MRI with Gadolinium injection (Other)
TIPS group
TIPS group : Adults with decompensated cirrhosis referred for transjugular intrahepatic portosystemic shunt (TIPS). Participants undergo 4D-flow liver MRI before and after TIPS placement, invasive pressure measurements, blood sampling, and 6-month follow-up to assess post-TIPS outcomes.
干预措施: 4D-Flow Liver and heart MRI with Gadolinium injection (Other)
MASLD group
MASLD group : Adults with compensated cirrhosis related to metabolic dysfunction-associated steatotic liver disease (MASLD). Participants undergo invasive HVPG measurement and 4D-flow liver MRI, with 6-month follow-up to assess portal hypertension-related complications and prognostic value of imaging parameters.
干预措施: Samples Without DNA (Biological)
结局指标
主要结局
Correlation between invasive hepatic venous pressure gradient (HVPG) and quantitative hepatic 4D-flow MRI hemodynamic parameters
时间窗: Baseline (4D-flow MRI performed within 3 days before or after invasive measurements)
The primary outcome is the association between the invasive hepatic venous pressure gradient (HVPG; wedged hepatic venous pressure minus free hepatic venous pressure) measured during transjugular catheterization and quantitative hepatic 4D-flow MRI-derived parameters, including flow rate and peak velocity in the portal venous system (main portal vein and right/left branches), splenic vein, superior mesenteric vein, hepatic veins, and inferior vena cava. When available, direct portal pressure will be recorded as supportive invasive data
次要结局
- : Correlation between 4D Flow MRI measured flows and the percentage of shunt with the incidence of events related to portal hypertension(6 months)
- Correlation between proteomic signatures and the occurrence of hepatic encephalopathy(Occurrence of hepatic encephalopathy will be monitored for 6 months following the TIPS procedure)
- Correlation between transcriptomic signatures and the occurrence of hepatic encephalopathy(Occurrence of hepatic encephalopathy will be monitored for 6 months following the TIPS procedure)
- Correlation between metabolomic signatures and the occurrence of hepatic encephalopathy.(Occurrence of hepatic encephalopathy will be monitored for 6 months following the TIPS procedure)
- Correlation between viromic signatures and the occurrence of hepatic encephalopathy(Occurrence of hepatic encephalopathy will be monitored for 6 months following the TIPS procedure)
- Correlation between bacteriomic signatures and the occurrence of hepatic encephalopathy(Occurrence of hepatic encephalopathy will be monitored for 6 months following the TIPS procedure)
- Correlation between TIPS diameter and hemodynamic measurements and 4D Flow MRI results before and after TIPS(TIPS diameter measured immediately after the procedure)
- Correlation between 4D Flow MRI results and hemodynamic measurements before and after TIPS(4D Flow MRI performed within 3 days before and 3 days after TIPS)
- Correlation between 4D Flow MRI-measured flow rates and the percentage of shunt with the occurrence of TIPS-related and/or portal hypertension-related complications within 6 months following TIPS(Complications will be monitored for 6 months following the TIPS procedure)
- Correlation between 4D Flow MRI flow-rate changes and shunt percentage before and after TIPS, and the occurrence of TIPS- or portal hypertension-related complications within 6 months, in relation to these flow-rate and shunt changes(Complications will be monitored for 6 months following the TIPS procedure.)
- Evaluation of the variation in 4D Flow MRI-measured flow rates and percentage of shunt before and after TIPS, according to TIPS diameter(Flow measurements and shunt percentage will be assessed before and after TIPS (within 3 days before and 3 days after TIPS).)
- Correlation between changes in ammonia levels before and after TIPS with changes in percentage of shunt before and after TIPS(Ammonia levels and shunt percentage will be measured within 3 days before and 3 days after TIPS)
- Correlation between proteomic signatures (before TIPS and the occurrence of hepatic encephalopathy within 6 months following TIPS(before TIPS, with follow-up for the occurrence of hepatic encephalopathy during the 6 months after TIPS)
- Correlation between transcriptomic signatures (before TIPS and the occurrence of hepatic encephalopathy within 6 months following TIPS(before TIPS, with follow-up for the occurrence of hepatic encephalopathy during the 6 months after TIPS)
- Correlation between metabolomic signatures (before TIPS and the occurrence of hepatic encephalopathy within 6 months following TIPS(before TIPS, with follow-up for the occurrence of hepatic encephalopathy during the 6 months after TIPS)
- Correlation between bacteriomic signatures (before TIPS and the occurrence of hepatic encephalopathy within 6 months following TIPS(before TIPS, with follow-up for the occurrence of hepatic encephalopathy during the 6 months after TIPS)
- Correlation between viromic signatures (before TIPS and the occurrence of hepatic encephalopathy within 6 months following TIPS(before TIPS, with follow-up for the occurrence of hepatic encephalopathy during the 6 months after TIPS)