A prospective, single-centre pilot trial to evaluate the feasibility and safety of ultrasound-guided direct portal vein pressure gradient measurement in patients with non-neoplastic hepatic disorders

Kantonsspital St. Gallen0 个研究点目标入组 18 人开始时间: 2023年11月21日最近更新: 2023年12月4日

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•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

•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

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