Efficacy and Safety of Percutaneous Liver Biopsy With Needle Tract Plugging on Outpatient Basis

Study Overview
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Brief Summary
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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.

Detailed Description
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Adult patients who are referred for the ultrasound-guided percutaneous biopsy of focal liver lesion (larger than 1cm) to obtain three or more tissue cores are eligible for this study. Exclusion criteria are as follows: 1) unable to approach a target lesion under ultrasound-guidance; 2) severe coagulopathy; 3) unable to discontinue anticoagulant/antiplatelet medications for the duration proposed by 2019 Society of Interventional Radiology guidelines; 4) co-presence of amyloidosis, large amount of ascites, or acute hepatobiliary infections. All enrolled patients will be randomized into either the conventional group or coaxial/plugging group. The conventional group will undergo percutaneous liver biopsy for multiple tissue cores through multiple punctures of the liver capsule. The coaxial/plugging group will undergo percutaneous liver biopsy using a coaxial needle (single puncture of the liver capsule), which will be plugged by gelatin particles after obtaining multiple tissue cores. The biopsy will be performed on outpatient basis regardless of the randomized group, and the patients will be discharged after two hours of observation. The rate of biopsy-related complications including bleeding (minor and major) and diagnostic yield will be compared between the two groups.

Official Title
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Efficacy and Safety of Percutaneous Liver Biopsy With Needle Tract Plugging on Outpatient Basis: a Randomized Study (COGEL Study; Coaxial With Gelatin)

Conditions
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Image-guided Biopsy, Liver Biopsy

Intervention / Treatment
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* Procedure: Conventional method
* Procedure: Coaxial method with needle-track plugging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients aged 19 years or older in this institution Patients referred for imaging-guided percutaneous liver biopsy requiring three or more tissue cores Patients who understand and consent to enrollment in this study Target lesion diameter 1cm or larger, and the lesion is approachable under ultrasonography-guidance. Exclusion Criteria: Patients with severe psychologic disorder or mental retardation Patients with poor cooperation Severe coagulopathy Hepatobiliary obstruction Acute hepatobiliary infection Large amount of ascites Amyloidosis Patients on antiplatelet/anticoagulant medication that cannot be discontinued for a specified period of time Other patients whom the researchers deem ineligible

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Enrolled patients will be randomly allocated to either the conventional group or coaxial/plugging group for percutaneous liver biopsy. After the procedure, the rates of biopsy-related complications as well as diagnostic yield will be compared.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional<br>Percutaneous liver biopsy is carried out through multiple punctures of liver capsule. | Procedure: Conventional method<br>* The conventional method utilizes a 18G biopsy gun to acquire three or more tissue cores with the corresponding number of liver capsule punctures. Plugging of the biopsy needle track is not performed.<br>|
| Experimental: Coaxial/plugging<br>Percutaneous liver biopsy is carried out through single puncture of liver capsule using coaxial needle and subsequent needle tract plugging. | Procedure: Coaxial method with needle-track plugging<br>* The coaxial method utilizes a 17G coaxial needle with 18G biopsy gun to acquire three or more tissue cores with a single liver capsule puncture. Biopsy needle track is plugged using a slurry of gelatin particles (EGgel S Plus 2000-4000 μm).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of percutaneous liver biopsy | Number of successfully acquired tissue cores; Diagnostic yield | 1 week |