Status:
COMPLETED
Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements
Lead Sponsor:
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Collaborating Sponsors:
Iuliu Hatieganu University of Medicine and Pharmacy
Conditions:
Cirrhosis
Vascular Diseases
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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, t...
Detailed Description
Number of patients needed to be included: To achieve the first primary objective, the investigators will include 20 patients. To achieve the second primary objective, 30 patients will be included, wi...
Eligibility Criteria
Inclusion
- patients with cirrhosis undergoing TIPS placement and patients with presinusoidal portal hypertension and patients with portal vein thrombosis
Exclusion
- Patient is \< 18 or \> 85 years of age
- 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
- Previous transjugular intrahepatic or surgical portosystemic shunt
- Previous total or partial splenectomy
- 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
- Patients with current advanced hepatocellular carcinoma (HCC)
- Emergent salvage TIPS placement in patients with failure to control bleeding
- Severe coagulopathy
- Anatomic abnormalities of the hepatic vasculature that prevent access to the intrahepatic portion of the portal vein or hepatic veins
- Evidence of active gastrointestinal bleeding
- If the volume of ascites in the path of the needle prevents apposition of the gastrointestinal tract and liver
- Allergies to iodine contrast
Key Trial Info
Start Date :
January 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06216509
Start Date
January 10 2023
End Date
December 20 2024
Last Update
February 25 2025
Active Locations (1)
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1
Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor
Cluj-Napoca, Cluj, Romania, 400158