Ultrasound-guided direct measurement of pressure in the portal vein Not Applicable
Conditions
Interventions
A non-randomized, open, clinical pilot study to assess the feasibility and safety of a new approach to measure portal pressure by ultrasound-guided direct measurement of pressure in the portal vein pa
Sponsors
Kantonsspital St. Gallen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measure: 1. Reproducibility is measured by evaluating the number of patients for whom the portal pressure gradient value is reproducible by repeated measurement of portal venous and hepatic venous pressure at three times per patient, whereby PPG values are rated as reproducible and plausible if the range of values between highest and lowest value is =3 mmHg in a patient. Safety outcome measure: 1. Number and type of intervention-related adverse events and serious adverse events in patients from study intervention until follow-up at 1 month. Other outcome measures of interest: 1. Distribution of individual patient’s PPG values, PV and HV measurements in relation to liver biopsy result, transient elastography result and clinical parameters from the day of the study intervention are listed descriptively. 2. Distribution of intervention-related pain ratings assessed by the patient’s subjective assessment of pain intensity on the Verbal Numerical Pain Rating Scale (VNPRS-11) right after ultrasound concluding the study intervention and earliest at 3 hours after the study intervention. 3. User acceptance of the study intervention assessed using a self-report questionnaire right after the conduct of the study intervention. | — |
Countries
Switzerland
Outcome results
None listed