Chronic Liver DiseaseNCT04806607
19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB)
A study testing 19G FNB and 22G FNB in people with Chronic Liver Disease, run by Geisinger Clinic at 1 site in United States.
Trial summary
To determine the adequacy of EUS-LB using a 19G core needle compared to a 22G core needle in a prospective randomized study. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- 19G FNB and 22G FNB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2021to 16 Mar 2022
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing EUS-LB
- Platelet Count > 50,000
- International normalized ratio (INR) < 1.5
- Age > 18 years of age
- Non-Pregnant Patients
Who cannot join
- Age < 18 Years of Age
- Pregnant Patients
- Inability to obtain consent
- Anticoagulants or anti-platelet agents (excluding aspirin) within the last 7 -10 days
- Platelet count < 50,000
- Presence of Ascites
- Known Liver Cirrhosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Medical Center
Danville, Pennsylvania, 17822
About this study
Official title: 19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Randomized Prospective Trial
To determine the adequacy of EUS-LB using a 19G core needle compared to a 22G core needle in a prospective randomized study.
Read the detailed description
The 19Gauge core and 22Gauge core needles have both been used for EUS-LB with good success. Previous studies have reported good safety and tissue adequacy with both the needles, but the head-on comparison between these two needles is lacking.
This is a prospective randomized trial comparing the biopsy specimen adequacy of 19Gauge versus 22Gauge core needles for EUS-LB.
- Conditions
- Chronic Liver Disease
- Being tested
- 19G FNB, 22G FNB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
19G FNBProcedure or surgery
Biopsy specimen adequacy using the 19G FNB
22G FNBProcedure or surgery
Biopsy specimen adequacy using the 22G FNB.
| Study group | Role | What they receive |
|---|---|---|
| 19Gauge Fine Needle Biopsy | Active comparator | 19Gauge Fine Needle Receives: Procedure: 19G FNB; Procedure: 22G FNB |
| 22 Gauge Fine Needle Biopsy | Active comparator | 22Gauge Fine Needle Receives: Procedure: 19G FNB; Procedure: 22G FNB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Longest Piece
Length of the longest piece of the liver tissue obtained
Measured: Up to 5 Days
Secondary outcomes (4)
Aggregate Specimen Length
Cumulative length of all the pieces of tissue obtained
Measured: 3 to 5 Days
Degree of Fragmentation
Size of the fragments of the samples will be measured, then classified as small (<5 mm), medium (5-8 mm) or large (>8 mm), then compared for the 2 needles
Measured: 3 to 5 Days
Number of Portal Tracts in the Specimen
Number of portal triads will be counted in the specimens and compared for the 2 needles
Measured: 3 to 5 Days
Adverse Events and Serious Adverse Events
Untoward, undesired, or unplanned event
Measured: 7 to 10 Days Post Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start30 Apr 2021
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- 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
- This is a prospective randomized trial comparing the biopsy specimen adequacy of 19G versus 22G core needles in subjects undergoing an EUS-LB.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David L. Diehl, Geisinger Clinic
- Investigators
- David L Diehl, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806607
- Sponsor's protocol ID
- 2020-1072
- Status last verified
- Apr 2022
- First submitted
- 17 Mar 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diehl DL, Sangwan V, Johal AS, Khara HS, Confer B. Comparing a 19-gauge fine-needle biopsy needle with a 22-gauge fine-needle biopsy needle for EUS-guided liver biopsy sampling: a prospective randomized study. Gastrointest Endosc. 2024 Jun;99(6):931-937. doi: 10.1016/j.gie.2023.12.022. Epub 2023 Dec 21.
PubMed 38141686
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT04806607
- Acronym / sponsor ID
- 2020-1072
- Conditions
- Chronic Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 19 Mar 2021 (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.
To determine the adequacy of EUS-LB using a 19G core needle compared to a 22G core needle in a prospective randomized study.
Detailed description
The 19Gauge core and 22Gauge core needles have both been used for EUS-LB with good success. Previous studies have reported good safety and tissue adequacy with both the needles, but the head-on comparison between these two needles is lacking.
This is a prospective randomized trial comparing the biopsy specimen adequacy of 19Gauge versus 22Gauge core needles for EUS-LB.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective randomized trial comparing the biopsy specimen adequacy of 19G versus 22G core needles in subjects undergoing an EUS-LB.
| Arm | Type | Receives |
|---|---|---|
| 19Gauge Fine Needle Biopsy | Active comparator | Procedure: 19G FNB, Procedure: 22G FNB19Gauge Fine Needle |
| 22 Gauge Fine Needle Biopsy | Active comparator | Procedure: 19G FNB, Procedure: 22G FNB22Gauge Fine Needle |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing EUS-LB
- Platelet Count > 50,000
- International normalized ratio (INR) < 1.5
- Age > 18 years of age
- Non-Pregnant Patients
Key exclusion criteria (7 listed)
- Age < 18 Years of Age
- Pregnant Patients
- Inability to obtain consent
- Anticoagulants or anti-platelet agents (excluding aspirin) within the last 7 -10 days
- Platelet count < 50,000
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 |
|---|---|---|
| 19G FNBBiopsy specimen adequacy using the 19G FNB | Procedure or surgery | 19Gauge Fine Needle Biopsy, 22 Gauge Fine Needle Biopsy |
| 22G FNBBiopsy specimen adequacy using the 22G FNB. | Procedure or surgery | 19Gauge Fine Needle Biopsy, 22 Gauge Fine Needle Biopsy |
Primary outcome
Length of Longest Piece
Time frame: Up to 5 Days
Length of the longest piece of the liver tissue obtained
4 secondary outcomes
Aggregate Specimen Length
Time frame: 3 to 5 Days
Degree of Fragmentation
Time frame: 3 to 5 Days
Number of Portal Tracts in the Specimen
Time frame: 3 to 5 Days
Adverse Events and Serious Adverse Events
Time frame: 7 to 10 Days Post Procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Derived from this study: PubMed 38141686Diehl DL, Sangwan V, Johal AS, Khara HS, Confer B. Comparing a 19-gauge fine-needle biopsy needle with a 22-gauge fine-needle biopsy needle for EUS-guided liver biopsy sampling: a prospective randomized study. Gastrointest Endosc. 2024 Jun;99(6):931-937. doi: 10.1016/j.gie.2023.12.022. Epub 2023 Dec 21.
- Individual participant dataSharing planned: No
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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.
David L Diehl, MD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 19G FNB and 22G FNB in people with Chronic Liver Disease, run by Geisinger Clinic at 1 site in United States.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 20 Apr 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Longest Piece (time frame: Up to 5 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04806607, which also lists 1 linked publication.
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 20 Apr 2022.