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

Not Applicable

Recruiting

• Conditions: Image-guided Biopsy; Liver Biopsy
• Interventions: Procedure: Coaxial method with needle-track plugging; Procedure: Conventional method

• Registration Number: NCT05614973
• Lead Sponsor: Yonsei University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-08-02
• Status Verified: 2022-11
• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-10
• Last Update Submitted: 2022-11-10
• Study First Posted: 2022-11-14
• Last Update Posted: 2022-11-14
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coaxial/plugging	Coaxial method with needle-track plugging	Percutaneous liver biopsy is carried out through single puncture of liver capsule using coaxial needle and subsequent needle tract plugging.
Conventional	Conventional method	Percutaneous liver biopsy is carried out through multiple punctures of liver capsule.

Primary Outcome Measures

Name	Time	Method
Safety of percutaneous liver biopsy	Day 7 after procedure	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy of percutaneous liver biopsy	1 week	Number of successfully acquired tissue cores; Diagnostic yield

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of