NCT06216509Completed
Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements
Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements in Patients with Cirrhosis and Non Cirrhotic Portal Hypertension
Source: ClinicalTrials.gov · Last updated 25 Feb 2025
Brief summary (registry, in English)
Portal hypertension (PHT) is the main consequence of advanced chronic liver diseases (ACLD) and is often associated with severe complications leading to increased morbidity and mortality. Currently, the gold standard for the evaluation of the severity of PHT is the hepatic venous-pressure gradient (HVPG). The disadvantage of using the HVPG, besides the availability of the technique only in referral centres, is in the case of patients with vascular liver disorders because the HVPG underestimates the severity of PHT. Recent studies have evaluated the feasibility of the pressure gradient measurement through endoscopic transgastric and transhepatic access using special kit with a 25-gauge FNA needle (Cook Medical, Winston-Salem, NC, USA) and a compact manometer (Cook Medical, Bloomington, Ind, USA) that has the disadvantage of high purchase cost, no tracing of pressure possible and has not yet been properly correlated with the gold standard HVPG measurement or PPG measurement thus limiting its use in current practice. The aim of the study is 1. to assess and compare the correlations in the porto-systemic gradient measurement between a) direct portal vein puncture during TIPS insertion, b) direct portal and hepatic pressure measurements using a 22 Gauge FNA needle during endoscopic ultrasound procedure and c) indirect portal vein pressure measurements using the interventional radiology based hepatic HVPG procedure in patients with cirrhosis submitted to TIPS procedure for complications of portal hypertension and 2. To evaluate and compare the porto-systemic gradient obtained by direct portal and hepatic pressure measurements using a 22 Gauge FNA needle during endoscopic ultrasound and indirect measurement through HVPG measuring in patients with presinusoidal hypertension and those with portal vein thrombosis.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 16 Feb 2023
- Start date
- 10 Jan 2023
- Primary completion date
- 20 Nov 2024
- Lead sponsor
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
- Diseases
- High blood pressure
- NCT number
- NCT06216509
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 10 Jan 2023 to the primary completion date, 20 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous transjugular intrahepatic or surgical portosystemic shunt
- Previous total or partial splenectomy
Other illness
- Known history of spontaneous bacterial peritonitis (SBP) within the last three months irrespective of treatment for SBP
- Patients with known infection which is not controlled by medical intervention
- Severe Portopulmonary hypertension contraindicating TIPS placement
- Cardiac decompensation
- Cholestatic liver disease
- Emergent salvage TIPS placement in patients with failure to control bleeding
- Evidence of active gastrointestinal bleeding
- Allergies to iodine contrast
Age
- Patient is \< 18 or \> 85 years of age
Other
- Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study
- Patient is unwilling or unable to sign and date the informed consent
- Patient for whom endoscopic procedures are contraindicated
- Patients for whom propofol general anesthesia is contraindicated
- Patients with current advanced hepatocellular carcinoma (HCC)
- Severe coagulopathy
- Anatomic abnormalities of the hepatic vasculature that prevent access to the intrahepatic portion of the portal vein or hepatic veins
- If the volume of ascites in the path of the needle prevents apposition of the gastrointestinal tract and liver
Who the study is looking for
- patients with cirrhosis undergoing TIPS placement and patients with presinusoidal portal hypertension and patients with portal vein thrombosis
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.