Hepatic Venous Pressure Gradient and Elastography in Porto-sinusoidal Vascular Disorder
Sponsored by Universidade Federal do Rio de Janeiro
About this trial
Last updated 2 years ago
Study ID
PSVD-1
Status
Not yet recruiting
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18 to 80 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended a year ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
- Age ≥ 18 years;
- Patients with specific signs of portal hypertension:
1. Endoscopic: esophagogastric/ectopic varices;
2. On imaging (US, CT or MRI): portosystemic collateral veins;
- Transient hepatic elastography with valid values ≤ 20 kPa;
- Signed written informed consent form.
Exclusion Criteria
- Contraindications to HVPG or percutaneous liver biopsy:
1. Pregnancy
2. Allergy to iodine
3. Chronic kidney disease with creatinine clearance < 50 ml/min
4. Anticoagulation
5. RNI > 1.5
6. Platelets < 50,000/mm3
- Confounding factors:
1. Hepatitis C treated with SVR
- Conditions that exclude the diagnosis of PSVD:
1. History of bone marrow transplant
2. Budd-Chiari
3. Congestive heart failure or Fontan surgery
4. Abernethy's Syndrome
5. Hereditary hemorrhagic telangiectasia
6. Chronic cholestatic diseases
7. Neoplastic hepatic infiltration
8. Sarcoidosis
9. Congenital hepatic fibrosis
10. Hepatosplenic schistosomiasis
11. Portal cavernoma / thrombosis with complete occlusion of the main portal vein.