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

NCT05614973 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2022-11-14

No results posted yet for this study

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

Interventions

PROCEDURE

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.

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).

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Seung-seob Kim · Severance hospitalDepartment of Radiology, Severance Hospital, Yonsei University College of Medicine, Korea

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-02
Primary Completion
2023-08-31
Completion
2023-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05614973 on ClinicalTrials.gov