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Portal Hypertension clinical trials

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NCT ID: NCT05789641 Recruiting - Portal Hypertension Clinical Trials

Multimodal Ultrasound and Portal Hypertension

Start date: March 23, 2020
Phase:
Study type: Observational

According to international guidelines, Hepatic Venous Pressure Gradient is the gold standard technique for portal hypertension measurement, but it is invasive and poorly available. Currently, surveillance of oesophageal/gastric varices is performed by upper gastrointestinal endoscopy. More recently, non-invasive tools to estimate portal hypertension have been developed and, among them, ultrasound elastography has been proposed as a technique to stratify patient risk to have portal hypertension. Aim of this study is to evaluate the relationship between ultrasound evaluation (D-CEUS + elastography) and endoscopic parameters predictive of clinically significant portal hypertension in patients with liver cirrhosis.

NCT ID: NCT05782556 Recruiting - Liver Cirrhosis Clinical Trials

Freiburg TIPS Registry

FRETIR
Start date: January 1, 2023
Phase:
Study type: Observational [Patient Registry]

Patients with clinically significant portal hypertension allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Medicine II of the University Medical Center Freiburg, Germany will be offered to participate in this prospective observational trial. Clinical and laboratory as well as outcome parameters will be assessed before and within the first 12 months after TIPS implantation following a regular follow-up schedule with clinical visits at the University Medical Center Freiburg. During follow-up visits, serum/plasma samples and peripheral blood mononuclear cells (PBMC) are collected and stored in a associated biobank.

NCT ID: NCT05767229 Recruiting - Portal Hypertension Clinical Trials

Acute Hemodynamic Response to Carvedilol in Children With Clinically Significant Portal Hypertension.

Start date: March 13, 2023
Phase: N/A
Study type: Interventional

Clinically significant portal hypertension (CSPH) is defined as Hepatic Venous Pressure gradient (HVPG) >10 mmHg. Patients with CSPH are at risk of developing esophageal varices and clinical decompensation (variceal bleeding, ascites, jaundice, encephalopathy), which mark the transition from compensated stage to a stage of the disease (decompensated) associated with higher mortality. HVPG is calculated by subtracting the free hepatic venous pressure (FHVP), a measure of systemic pressure, from the wedged hepatic venous pressure (WHVP), a measure of hepatic sinusoidal pressure. HVPG is surrogate marker in many clinical applications such as gold standard test to evaluate presence and severity of portal hypertension (PHT) diagnosis, risk stratification, monitoring of the patients on beta blockers. Non-selective beta-blockers like propranolol and carvedilol are indicated in adults for primary and secondary prophylaxis of variceal hemorrhage. Acute hemodynamic response to intravenous propranolol with HVPG values coming down to < 12 mm Hg or reduction to >20% from baseline have been shown to be associated with reduced long-term risk of variceal bleed. Portal Hypertension in biliary atresia (BA) occurs early and is due to recurrent cholangitis and portal sclerosis. HVPG in children is feasible and safe in children according to previous studies, however, there are no recommendations to suggest beta-blockers based on HVPG reduction in children. Hence, we are planning the current work to study the acute hemodynamic response to carvedilol in children with CSPH, and to compare the HVPG values in children with chronic liver disease.

NCT ID: NCT05765253 Terminated - Vascular Diseases Clinical Trials

Achieving Portal Access With Scorpion Post-Approval Study (APASS)

Start date: July 13, 2023
Phase: N/A
Study type: Interventional

Creation of the parenchymal tract between the portal vein and the hepatic vein is the most difficult and time consuming step in a TIPS procedure. The purpose of this study is to evaluate portal vein access sets during the TIPS procedure.

NCT ID: NCT05749198 Completed - Portal Hypertension Clinical Trials

Portal Hypertension Using Magnetic Resonance Elastography

Start date: January 2, 2018
Phase:
Study type: Observational

This prospective study was conducted in a tertiary university hospital. The investigators researched the correlation between MRE-assessed stiffness of the liver and spleen and the Hepatic venous pressure gradient (HVPG) values. Furthermore, the investigator evaluated whether MRE-assessed stiffness reflected changes in portal hypertension (PH) after administering non-selective beta-blockers (NSBBs).

NCT ID: NCT05719857 Not yet recruiting - Portal Hypertension Clinical Trials

Hepatic Venous Pressure Gradient and Elastography in Porto-sinusoidal Vascular Disorder

Start date: March 2023
Phase: N/A
Study type: Interventional

Porto-sinusoidal vascular disorder (PSVD) is considered a rare cause of portal hypertension (PH), resulting from specific histological alterations that essentially affect the small portal branches and sinusoids, in the absence of cirrhosis. In recent years, the recognition and importance of PSVD has increased, notably due to the widespread use of transient elastography (TE). However, the definitive diagnosis of PSVD can only be established through liver biopsy. Recent data show that PSVD should be suspected in patients with PH and TE ≤ 20 kPa and liver biopsy should be considered in this context. The investigators hypothesize that hepatic venous pressure gradient (HVPG) and magnetic resonance liver elastography (MRE) may help in the selection of liver biopsy candidates for the diagnosis of PSVD. The primary objective of the study is to describe HVPG and MRE values and liver biopsy findings in patients with PH and TE ≤ 20 kPa. The search for serum markers that can distinguish these patients from those with cirrhotic portal hypertension without the need for liver biopsy will also be the object of this study. 50 patients will be included, prospectively and retrospectively, in a comparative study between diagnostic methods, with a cross-sectional design.

NCT ID: NCT05704192 Recruiting - Clinical trials for Hepatocellular Carcinoma

CT-based HVPG Assessment for Predicting the Prognosis of HCC With TACE (CHANCE-CHESS 2302)

Start date: May 4, 2023
Phase:
Study type: Observational

This study aims to evaluate the impact of non-invasive CT-based Hepatic Venous Pressure Gradient (HVPG) assessment on prognosis of hepatocellular carcinoma (HCC) patients treated with transarterial chemoembolization (TACE).

NCT ID: NCT05703750 Recruiting - Clinical trials for Hepatocellular Carcinoma

Impact of Clinical Evident Portal Hypertension on HCC With TACE (CHANCE-CHESS 2301)

Start date: May 4, 2023
Phase:
Study type: Observational

The purpose of this study is to discuss the prognostic value of CEPH among HCC patients underwent TACE treatment, its impact on overall survival, and try to stratify patient cohorts for a better treatment strategy.

NCT ID: NCT05689268 Completed - Cirrhosis Clinical Trials

EUS-PPG vs HVPG in Portal Hypertension

GRAPE
Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the correlation of the calculated portal pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with a conventional 22 G needle guided by EUS and indirect portal vein pressure measurements using the interventional radiology based hepatic venous pressure gradient (HVPG) procedure.

NCT ID: NCT05653115 Recruiting - Clinical trials for Bariatric Surgery Candidate

Portal Hypetension and Bariatric Surgery (BARIAPORTAL)

BARIAPORTAL
Start date: January 12, 2022
Phase:
Study type: Observational

The worldwide obesity epidemic has led to an increase in the proportion of patients with chronic liver disease due to non-alcoholic fatty liver disease (NAFLD) and in the prevalence of obesity in patients with cirrhosis of all etiologies. The reported prevalence of obesity in patients with cirrhosis is of 30% which appears similar to that of the general population. Bariatric surgery is currently considered as the most effective and durable means for the management of morbid obesity as it is associated with the remission and/or improvement of many obesity associated comorbidities as well as improved quality and expectancy of life. However, the surgical risk is increased compared to individuals without cirrhosis, and determining the risk/benefit ratio of bariatric surgery in the setting of cirrhosis is a complex task further hampered by the lack of randomized controlled trials. The Nationwide Inpatient Sample study reported a slightly increased rate of mortality of bariatric surgery in the setting of compensated cirrhosis compared to individuals without cirrhosis (0.9% vs 0.3%). Interestingly, this risk was as high as 16.3% in individuals with decompensated cirrhosis (16.3%). However, this study has been published more than 10 years ago and the mortality of bariatric surgery has decreased significantly and is around 0.1%. Furthermore, the introduction of transient elastography in clinical practice has allowed the early identification of patients with chronic liver disease (CLD) at risk of developing clinically significant portal hypertension (CSPH). A few series including a limited number of patients have been published indicating that CSPH should not be considered as a formal contraindication for bariatric surgery. This study is meant to assess the outcomes of bariatric surgery in patients with morbid obesity and compensated advanced chronic liver disease (cACLD) (currently synonymous of the term "compensated cirrhosis'') associated with clinically significant portal hypertension (CSPH) in a large multicentric, multinational series.