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

NCT05614973 | Unknown

• 1 other identifier: 4-2022-0211
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Image-guided Biopsy; Liver Biopsy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Efficacy of percutaneous liver biopsy

  1 week

Study Arms (2)

Conventional

ACTIVE COMPARATOR

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

Procedure: Conventional method

Coaxial/plugging

EXPERIMENTAL

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

Interventions

Conventional method 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.

Conventional

Coaxial method with needle-track plugging 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).

Coaxial/plugging

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

Study Officials

• Seung-seob Kim

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung-seob Kim

CONTACT

+82-10 2600 1027; K2S0127@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 14, 2022
• Study Start: August 2, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

KR (1)