Study to measure the direct portal vein pressure gradient in patients with liver disease

Not Applicable

Completed

• Conditions: ltrasound-guided direct measurement of pressure in the portal vein; Not Applicable

• Registration Number: ISRCTN11916601
• Lead Sponsor: Kantonsspital St. Gallen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-07-08
• Study Start: 2023-11-21
• Last Update Posted: 4 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Patient planned to undergo transient elastography and percutaneous liver biopsy via the right lobe of the liver in frame of standard diagnostics for non-neoplastic hepatic disorders regardless of the stage of fibrosis
2. Patient available for planned follow-up for at least 1 month
3. Male or female aged =18 years
4. Must be willing and able to give written informed consent to participate in the study and agree to comply with the study protocol prior to initiation of any study-mandated procedure and study intervention

Exclusion Criteria

1. Patient with primary neoplastic hepatic disorders and/or liver metastasis
2. Patient planned to undergo biopsy of a focal liver lesion or biopsy via the left lobe of the liver
3. Patient on any anticoagulation therapy at the time point of liver biopsy that cannot be stopped prior to actual conduct of liver biopsy
4. Patient having coagulation disorder defined as INR =1.5 and thrombocytes =70 G/l
5. Patient with Body Mass Index (BMI) =35
6. Patient with ascites
7. Patient with known allergies to ultrasound contrast agent SonoVue®
8. Patient with known right-to-left shunts, severe pulmonary hypertension (pulmonary arterial pressure > 90 mmHg), uncontrolled systemic hypertension or Respiratory Distress Syndrome (ARDS)
9. Patient on dobutamine therapy
10. Patient allergic to porcine collagen
11. Participation in another study with an investigational drug/device within the 30 days preceding and during the present study
12. Previous enrolment into the current study
13. Enrolment of the study investigator, his/her family members, employees and other dependent persons
14. If female and of childbearing potential: known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
Note: female patients who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child-bearing potential

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical feasibility is measured by evaluating the number of patients with valid portal pressure gradient* (PPG) derived from the means of ultrasound-guided measurements of direct portal venous pressure and direct hepatic venous pressure in a patient at the first attempt. A PPG value is rated as being valid and reliable if falling between 1 and 30 mmHg in a patient. *PPG is calculated by subtracting the mean hepatic venous (HV) pressure from the mean portal venous (PV) pressure.