EUS-PPG vs HVPG in Portal Hypertension (GRAPE)

Hospital General Universitario de Alicante

Status: Completed

Conditions: Portal Hypertension; Cirrhosis

Treatments: Diagnostic Test: EUS-PPG and HVPG

Study type: Interventional

Funder types: Other

Identifiers

NCT05689268

PI2021-135

Details and patient eligibility

About

The objective of this study is to evaluate the correlation of the calculated portal pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with a conventional 22 G needle guided by EUS and indirect portal vein pressure measurements using the interventional radiology based hepatic venous pressure gradient (HVPG) procedure.

Enrollment: 33 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age above 18 years
• Undergoing evaluation for chronic liver disease or portal hypertension
• Signed informed consent

Exclusion criteria

• Uncorrectable coagulopathy (INR above 1.5)
• Uncorrectable thrombocytopenia (Platelets under 50,000)
• Anticoagulation or antiplatelet therapy that cannot be discontinued
• Biliary obstruction
• Grade II ascites or more
• Intrahepatic portal vein thrombosis
• Pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

EUS-PPG and HVPG

Other group

Description:

EUS-PPG and HVPG will be measured in all patients. Under deep sedation with propofol, an echoendoscopy will be performed. After identifying the left or middle suprahepatic vein, it will be punctured with a standard 22 G needle. The needle will be previously purged with heparinized saline and connected to a venous pressure monitor via an arterial pressure system, which will be calibrated to zero at the level of the axillary midline, at the level of the atrium. Subsequently, the left portal vein will be identified from the stomach or duodenum, repeating the procedure. From each vessel 3 measurements will be taken by flushing 1-2 ml of heparinized saline. The mean of the three measurements will be obtained. On the same day or on successive days HVPG measurement will be performed.

Treatment:

Diagnostic Test: EUS-PPG and HVPG