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

Yonsei University

Status: Enrolling

Conditions: Liver Biopsy; Image-guided Biopsy

Treatments: Procedure: Conventional method; Procedure: Coaxial method with needle-track plugging

Study type: Interventional

Funder types: Other

Identifiers

NCT05614973

4-2022-0211

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Conventional

Active Comparator group

Description:

Percutaneous liver biopsy is carried out through multiple punctures of liver capsule.

Treatment:

Procedure: Conventional method

Coaxial/plugging

Experimental group

Description:

Percutaneous liver biopsy is carried out through single puncture of liver capsule using coaxial needle and subsequent needle tract plugging.

Treatment:

Procedure: Coaxial method with needle-track plugging