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

Liver Biopsy Clinical Trial

— COGEL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05614973
• Other study ID #: 4-2022-0211
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: November 2022
• Source: Yonsei University
• Contact: Seung-seob Kim
• Phone: +82-10 2600 1027
• Email: K2S0127[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Image-guided Biopsy
• Liver Biopsy

Intervention

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.
• 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).

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Efficacy of percutaneous liver biopsy	Number of successfully acquired tissue cores; Diagnostic yield	1 week