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

NCT05719857 | Unknown

• 1 other identifier: PSVD-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Portal Hypertension; Non-Cirrhotic Portal Hypertension; Non-Cirrhotic Portal Fibrosis; Regenerative Nodular Hyperplasia; Incomplete Septal Cirrhosis; Obliterative Portal Venopathy; Idiopathic Non-Cirrhotic Portal Hypertension; Hepatoportal Sclerosis; Idiopathic Portal Hypertension; Vascular Disorder of Liver

Outcome Measures

Primary Outcomes (3)

• Hepatic venous pressure gradient measurement

  To describe the measurement of the hepatic venous pressure gradient (in mmHg) in patients with portal hypertension and transient hepatic elastography ≤ 20 kPa.

  12 months

• Magnetic resonance elastography

  To describe hepatic (in kPa) and splenic (in kPa) stiffness measured by magnetic resonance elastography in patients with portal hypertension and transient hepatic elastography ≤ 20 kPa.

  12 months

• Liver biopsy major findings

  To describe the frequency of major histological findings for the diagnosis of portal sinusoidal vascular disorder (obliterative portal venopathy, regenerative nodular hyperplasia and incomplete septal cirrhosis) in patients with portal hypertension and transient hepatic elastography ≤ 20 kPa.

  12 months

Secondary Outcomes (5)

• Hepatic vein-to-vein communications

  12 months

• Liver biopsy minor findings

  12 months

• Non-invasive markers - von Willebrand antigen factor

  12 months

• Non-invasive markers - procollagen III amino-terminal peptide

  12 months

• Non-invasive markers - anti-endothelial cell antibodies

  12 months

Study Arms (1)

Portal hypertension patients with TE ≤ 20 kPa.

EXPERIMENTAL

All patients included will undergo HVPG measurement and US-guided percutaneous liver biopsy. The exams will be performed in sequence, in the laboratory of hepatic hemodynamics. Within 4 to 8 weeks, a multiparametric magnetic resonance imaging of the abdomen with elastography will be performed, concluding the protocol.

Procedure: Hepatic vein pressure gradient measurement; Procedure: Ultrasound-guided percutaneous liver biopsy; Diagnostic Test: Multiparametric Abdominal Magnetic Resonance with Elastography

Interventions

Hepatic vein pressure gradient measurement PROCEDURE

HVPG will be performed after light conscious sedation and with noninvasive vital sign monitoring. The right jugular vein will be catheterized with ultrasound assistance and after local anesthesia. Then a venous introducer will be placed and a balloon-tipped catheter will be advanced under fluoroscopic control into the right hepatic vein. Free hepatic pressure will be obtained with the balloon deflated, keeping the catheter tip in the right hepatic vein. Then, wedged venous pressure will be measured by inflating the balloon with 2 ml of air. At this moment, complete occlusion of the catheterized hepatic vein can be confirmed by injecting iodinated contrast and observing its retention. The presence of veno-venous communications can be detected during the test. To calculate the gradient, we perform the simple difference between the two measurements. Measurements will be performed in triplicate and the average used as the final value.

Also known as: HVPG

Portal hypertension patients with TE ≤ 20 kPa.

Ultrasound-guided percutaneous liver biopsy PROCEDURE

Percutaneous liver biopsy will be performed with the aid of US to choose the best site for the procedure, minimizing the incidence of complications. With the patient in dorsal decubitus, venous analgesia with fentanyl 25-50 mcg will be performed. After marking the appropriate site, skin asepsis and antisepsis will be performed with Chlorhexidine® and topical anesthesia with 1% lidocaine. Then, the liver will be punctured using a 14G semi-automatic tru-cut single-use liver biopsy needle. The recovered material will be stored in a 50 ml flask with 10% formaldehyde. Patients will remain at rest supervised for 4 hours, with hourly measurement of blood pressure (BP), heart rate (HR) and assessment of symptoms (abdominal pain, nausea, etc.). In the absence of any complications, patients will be discharged from the hospital.

Portal hypertension patients with TE ≤ 20 kPa.

Multiparametric Abdominal Magnetic Resonance with Elastography DIAGNOSTIC_TEST

The evaluation of the abdomen by MRI, with special interest to the liver and spleen, will be performed in a Siemens 3.0T Magnetom Prisma MR system. In addition to the routine protocol without contrast administration, MR elastography will be performed to assess liver stiffness and spleen stiffness. Data processing will be carried out at a Syngovia workstation.

Also known as: MRE

Portal hypertension patients with TE ≤ 20 kPa.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• Patients with specific signs of portal hypertension:
• Endoscopic: esophagogastric/ectopic varices;
• On imaging (US, CT or MRI): portosystemic collateral veins;
• Transient hepatic elastography with valid values ≤ 20 kPa;
• Signed written informed consent form.

You may not qualify if:

• Contraindications to HVPG or percutaneous liver biopsy:
• Pregnancy
• Allergy to iodine
• Chronic kidney disease with creatinine clearance \< 50 ml/min
• Anticoagulation
• RNI \> 1.5
• Platelets \< 50,000/mm3
• Confounding factors:
• \. Hepatitis C treated with SVR
• Conditions that exclude the diagnosis of PSVD:
• History of bone marrow transplant
• Budd-Chiari
• Congestive heart failure or Fontan surgery
• Abernethy's Syndrome
• Hereditary hemorrhagic telangiectasia

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Hospital Universitário Clementino Fraga Filho / Universidade Federal do Rio de Janeiro (UFRJ)

Rio de Janeiro, Rio de Janeiro, 21941-617, Brazil

Location

Related Publications (20)

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MeSH Terms

Conditions

Hypertension, Portal; Idiopathic Noncirrhotic Portal Hypertension

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Guilherme FM Rezende, MD, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guilherme FM Rezende, MD, PhD

CONTACT

+552199997-6292; guimottarezende@gmail.com

Eduardo Sica, MD

CONTACT

+5521995622626; eduardosica@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Comparative study between diagnostic methods, with a cross-sectional design.

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 9, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: July 1, 2024
• Last Updated: February 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)