Image-guided BiopsyCOGELNCT05614973
Efficacy and Safety of Percutaneous Liver Biopsy With Needle Tract Plugging on Outpatient Basis
A study testing Conventional method and Coaxial method with needle-track plugging in people with Image-guided Biopsy and Liver Biopsy, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Image-guided Biopsy, Liver Biopsy
- What is being tested?
- Conventional method and Coaxial method with needle-track plugging
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Aug 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with severe psychologic disorder or mental retardation
- Patients with poor cooperation
- Severe coagulopathy
- Hepatobiliary obstruction
- Acute hepatobiliary infection
- Large amount of ascites
Show all 9Show fewer
- Amyloidosis
- Patients on antiplatelet/anticoagulant medication that cannot be discontinued for a specified period of time
- Other patients whom the researchers deem ineligible
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Seung-seob Kim, +82-10 2600 1027, K2S0127@yuhs.ac
About this study
Official title: 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.
Read the 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.
- Conditions
- Image-guided Biopsy, Liver Biopsy
- Being tested
- Conventional method, Coaxial method with needle-track plugging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional methodProcedure or surgery
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 pluggingProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Percutaneous liver biopsy is carried out through multiple punctures of liver capsule. Receives: 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. Receives: Procedure: Coaxial method with needle-track plugging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 7 after procedure
Secondary outcomes (1)
Efficacy of percutaneous liver biopsy
Number of successfully acquired tissue cores; Diagnostic yield
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start2 Aug 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Image-guided BiopsyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seung-seob Kim, Principal investigator, Severance hospitalDepartment of Radiology, Severance Hospital, Yonsei University College of Medicine, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614973
- Sponsor's protocol ID
- 4-2022-0211
- Acronym
- COGEL
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Percutaneous Liver Biopsy With Needle Tract Plugging on Outpatient Basis: a Randomized Study (COGEL Study; Coaxial With Gelatin)
- ClinicalTrials.gov ID
- NCT05614973
- Acronym / sponsor ID
- COGEL / 4-2022-0211
- Conditions
- Image-guided Biopsy, Liver Biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Procedure: Conventional methodPercutaneous liver biopsy is carried out through multiple punctures of liver capsule. |
| Coaxial/plugging | Experimental | Procedure: Coaxial method with needle-track pluggingPercutaneous liver biopsy is carried out through single puncture of liver capsule using coaxial needle and subsequent needle tract plugging. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Patients with severe psychologic disorder or mental retardation
- Patients with poor cooperation
- Severe coagulopathy
- Hepatobiliary obstruction
- Acute hepatobiliary infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional methodThe 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 or surgery | Conventional |
| Coaxial method with needle-track pluggingThe 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). | Procedure or surgery | Coaxial/plugging |
Primary outcome
Safety of percutaneous liver biopsy
Time frame: During procedure
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.
Safety of percutaneous liver biopsy
Time frame: Day 1 after procedure
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.
Safety of percutaneous liver biopsy
Time frame: Day 7 after procedure
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.
1 secondary outcome
Efficacy of percutaneous liver biopsy
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-seob Kim principal investigator
Severance hospitalDepartment of Radiology, Severance Hospital, Yonsei University College of Medicine, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional method and Coaxial method with needle-track plugging in people with Image-guided Biopsy and Liver Biopsy, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung-seob Kim (+82-10 2600 1027, K2S0127@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of percutaneous liver biopsy (time frame: During procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.