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Clinical Trials/ISRCTN11916601
ISRCTN11916601
Completed
未知

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 sites18 target enrollmentNovember 21, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Kantonsspital St. Gallen
Enrollment
18
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 21, 2023
End Date
July 8, 2021
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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