Liver Biopsy Clinical Trial
— COGELOfficial title:
Efficacy and Safety of Percutaneous Liver Biopsy With Needle Tract Plugging on Outpatient Basis: a Randomized Study (COGEL Study; Coaxial With Gelatin)
A prospective, randomized, two-arm, single-center study to compare efficacy and safety of percutaneous ultrasound-guided liver biopsy of conventional method (multiple liver punctures) versus coaxial method followed by needle tract plugging.
Status | Recruiting |
Enrollment | 122 |
Est. completion date | August 31, 2023 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: 1. All adult patients aged 19 years or older in this institution 2. Patients referred for imaging-guided percutaneous liver biopsy requiring three or more tissue cores 3. Patients who understand and consent to enrollment in this study 4. Target lesion diameter 1cm or larger, and the lesion is approachable under ultrasonography-guidance. Exclusion Criteria: 1. Patients with severe psychologic disorder or mental retardation 2. Patients with poor cooperation 3. Severe coagulopathy 4. Hepatobiliary obstruction 5. Acute hepatobiliary infection 6. Large amount of ascites 7. Amyloidosis 8. Patients on antiplatelet/anticoagulant medication that cannot be discontinued for a specified period of time 9. Other patients whom the researchers deem ineligible |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yonsei University Health System, Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of percutaneous liver biopsy | Biopsy-related bleeding
Minor bleeding is defined as presence of linear flow signal along the needle tract on Doppler exam. Major bleeding is defined as bleeding which requires transfusion or vascular embolization. |
During procedure | |
Primary | Safety of percutaneous liver biopsy | Biopsy-related bleeding
Minor bleeding is defined as presence of linear flow signal along the needle tract on Doppler exam. Major bleeding is defined as bleeding which requires transfusion or vascular embolization. |
Day 1 after procedure | |
Primary | Safety of percutaneous liver biopsy | Biopsy-related bleeding
Minor bleeding is defined as presence of linear flow signal along the needle tract on Doppler exam. Major bleeding is defined as bleeding which requires transfusion or vascular embolization. |
Day 7 after procedure | |
Secondary | Efficacy of percutaneous liver biopsy | Number of successfully acquired tissue cores; Diagnostic yield | 1 week |
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