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

Efficacy and Safety of Percutaneous Liver Biopsy With Needle Tract Plugging on Outpatient Basis: a Randomized Study (COGEL Study; Coaxial With Gelatin)

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Biopsy; Image-guided Biopsy
• Intervention / Treatment: Procedure: Conventional method; Procedure: Coaxial method with needle-track 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 Type: Interventional
• Enrollment (Anticipated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seung-seob Kim; Phone Number: +82-10 2600 1027; Email: K2S0127@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei University Health System, Severance Hospital
    • Contact: Seung-seob Kim; Phone Number: +82-10 2600 1027; Email: K2S0127@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional; Percutaneous liver biopsy is carried out through multiple punctures of liver capsule.	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.
EXPERIMENTAL: Coaxial/plugging; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of percutaneous liver biopsy	Number of successfully acquired tissue cores; Diagnostic yield	1 week

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Seung-seob Kim, Severance hospitalDepartment of Radiology, Severance Hospital, Yonsei University College of Medicine, Korea

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 2, 2022
• Primary Completion (ANTICIPATED): August 31, 2023
• Study Completion (ANTICIPATED): August 31, 2023

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (ACTUAL): November 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 4-2022-0211

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No