Hepatic Venous Pressure Gradient Versus Endoscopic Ultrasound-Guided Portal Pressure Gradient - Comparative Analysis (HEPCA)

Sponsor
Military University Hospital, Prague
Study ID
NCT07424963
Status
Recruiting
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Conditions

  • Cirrhosis
  • EUS
  • HVPG
  • Hepatic Venous Pressure Gradient
  • Non-Cirrhotic Portal Hypertension
  • Portal Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Hepatic venous pressure gradient measurement — PROCEDURE
    HVPG measurement is minimally invasive procedure that involves cannulation of the right internal jugular vein, followed by the insertion of a balloon-occlusion catheter into the right or middle hepatic vein to measure both free hepatic vein pressure and wedged hepatic vein pressure, enabling the calculation of HVPG. Additionally, this method allows for liver biopsy during the same session. HVPG is widely regarded as the gold standard for PPG measurement.
  • Endoscopic ultrasound-guided portal pressure gradient measurement — PROCEDURE
    Recent advancements in the field of digestive endoscopy have introduced an innovative alternative: endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement. This emerging technique shows promise for further improving the accessibility of portal hypertension assessment and also offers the possibility of liver biopsy in one session. EUS-PPG may have several advantages, including its minimally invasive nature, safety profile, high technical success rate, the possibility of a "one-stopshop" approach (combining EUS-PPG, liver biopsy, and endoscopic treatment of esophageal varices), absence of radiation exposure.

Study Details

The goal of this interventional trial is to compare in measuring of portal hypertension by HVPG and EUS-PPG in subject indicated to HVPG measurement. The primary question is whether EUS-PPG provides measurements really equivalent to HVPG in terms of gradient accuracy. Participants undergoing HVPG will first undergo the procedure while conscious, performed by the first operator. Immediately thereafter, HVPG will be repeated following the induction of anesthesia by a second operator blinded to the initial readings. Subsequently, EUS-PPG will be performed by an endoscopist, who will also be blinded to all previous pressure measurements.

Key Dates

First listed
Feb 20, 2026
Start date
May 30, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Participants
    Participants undergoing HVPG will first undergo the procedure while conscious, performed by the first operator. Immediately thereafter, HVPG will be repeated following the induction of anesthesia by a second operator blinded to the initial readings. Subsequently, EUS-PPG will be performed by an endoscopist, who will also be blinded to all previous pressure measurements.

Primary Outcome Measure

Evaluation of the consistency between the HVPG and EUS-PPG [ Time Frame: 30 days after enrollment ]

Central Contacts

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