Clinical trial NCT05614973: Efficacy and Safety of Percutaneous Liver Biopsy With Needle Tract Plugging on Outpatient Basis
Official title: Efficacy and Safety of Percutaneous Liver Biopsy With Needle Tract Plugging on Outpatient Basis: a Randomized Study (COGEL Study; Coaxial With Gelatin)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Image-guided Biopsy
Liver Biopsy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 122
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Safety of percutaneous liver biopsy
timeFrame: During procedure
measure: Safety of percutaneous liver biopsy
timeFrame: Day 1 after procedure
measure: Safety of percutaneous liver biopsy
timeFrame: Day 7 after procedure
Secondary outcomes:
measure: Efficacy of percutaneous liver biopsy
timeFrame: 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Severance hospitalDepartment of Radiology, Severance Hospital, Yonsei University College of Medicine, Korea
name: Seung-seob Kim
role: PRINCIPAL_INVESTIGATOR
References: