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

NCT ID: NCT05614973

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2023-08-31

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.

Conditions

Image-guided Biopsy; Liver Biopsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Conventional

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

Group Type: ACTIVE_COMPARATOR

Conventional method

Intervention Type: PROCEDURE

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.

Coaxial/plugging

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

Group Type: EXPERIMENTAL

Coaxial method with needle-track plugging

Intervention Type: PROCEDURE

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).

Interventions

Conventional method

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.

Intervention Type: PROCEDURE

Coaxial method with needle-track plugging

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).

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seung-seob Kim

Role: PRINCIPAL_INVESTIGATOR

Severance hospitalDepartment of Radiology, Severance Hospital, Yonsei University College of Medicine, Korea

Locations

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Seung-seob Kim

Role: CONTACT

K2S0127@yuhs.ac

+82-10 2600 1027

Facility Contacts

Seung-seob Kim

Role: primary

K2S0127@yuhs.ac

+82-10 2600 1027

Other Identifiers

4-2022-0211

Identifier Type: -

Identifier Source: org_study_id