Hepatic Venous Pressure Gradient-guided Versus Standard Beta-blocker Therapy in Primary Prevention of Variceal Bleeding (Porthos)
Acute Bleeding Esophageal Varices, Liver Cirrhosis
About this trial
This is an interventional treatment trial for Acute Bleeding Esophageal Varices focused on measuring Prevention, Esophageal variceal bleeding, Hepatic Venous Pressure Gradient, Betablocker therapy
Eligibility Criteria
Inclusion Criteria:
Patients with liver cirrhosis Large (≥5 mm) esophageal varices
Exclusion Criteria:
- History of esophageal variceal hemorrhage
- Pregnancy
- Contraindications to beta-blocker therapy
- Esophageal varices in the absence of liver cirrhosis
- Intermediate, advanced or terminal stage hepatocellular carcinoma (BCLC stage B, C or D)
- Refractory ascites
- Hepatorenal syndrome
- Prior treatment or prophylaxis for esophageal varices or varices bleeding (propranolol use, TIPS, endoscopic banding ligation, endoscopic sclerotherapy)
Sites / Locations
- Universitair Ziekenhuis AntwerpenRecruiting
- Universitaire Ziekenhuizen LeuvenRecruiting
- Academisch Medisch CentrumRecruiting
- Free University Medical CentreRecruiting
- Leiden University Medical CentreRecruiting
- Haga HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
HVPG-propranolol arm
Propranolol arm
A baseline hepatic venous pressure gradient measurement (HVPG measurement) is performed in day-care setting. After this procedure propranolol is started at 20 mg BID. with dose escalation as described in the propranolol arm. A second HVPG measurement is performed at 4 weeks after adequate propranolol therapy. In patients who reach target HVPG reduction (responders), propranolol is continued at the same dose without routine control endoscopy. In patients who do not reach target HVPG reduction (nonresponders), endoscopic band ligation is performed in day-care setting with intervals of 2-4 weeks until complete obliteration of varices. Follow-up endoscopy with 6 months interval is performed to detect and treat recurrent large varices.
Propranolol start 20 mg BID. orally with dose escalation based on heart frequency (HF) with 3-days interval to the maximum tolerated dose. No routine control endoscopy is required.