Abnormal Liver FunctionNCT03408171

Comparison of 19g FNA and 19g FNB Needles for EUS-LB

A study testing 19-gauge FNA needle and 19-gauge FNB needle in people with Abnormal Liver Function, run by Geisinger Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Abnormal Liver Function
What is being tested?: 19-gauge FNA needle and 19-gauge FNB needle
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 2 Oct 2017to 17 Aug 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
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
Non-pregnant patients

Who cannot join

Age < 18 years
Pregnant patients
Inability to obtain consent
Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days
Platelet count < 50,000
INR > 1.5

Show all 9Show fewer

Presence of ascites
Known liver cirrhosis
Hemophilia

Trial locations and contacts

1 site in 1 country.

United States1 site

Geisinger Medical Center
Danville, Pennsylvania, 17822

Other trials in United States

About this study

Official title: 19-Gauge Fine Needle Aspirate (FNA) Versus 19-Gauge Fine Needle Biopsy (FNB) Needles for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Randomized Prospective Trial

Chronic liver disorders (CLD) are a major cause of morbidity and mortality for individuals in the US. Though serologic analysis will often lead to a conclusive diagnosis, liver biopsy remains an important method for helping to determine the etiology and stage of LD. Percutaneous liver biopsy (PLB), transjugular liver biopsy (TLB) and surgical liver biopsy (SLB) are alternative methods for obtaining hepatic tissue. In recent years endoscopic ultrasound guided-liver biopsy (EUS-LB) has come to the forefront as a safe and effective method for obtaining tissue in CLD. There are several studies of the safety of EUS-LB as well as the adequacy of specimens obtained in this fashion. Most studies involve a 19-g needle, therefore in this study we hope to compare the tissue yields of a 19-g fine needle biopsy (FNB) needle, in comparison to conventional 19-g fine needle aspiration (FNA) needle. We predict that 19-g FNA and 19-g FNB needle will demonstrate similar diagnostic accuracy, with less visible blood artifact. Similarly, we predict the safety to be equal.

Conditions: Abnormal Liver Function
Being tested: 19-gauge FNA needle, 19-gauge FNB needle
Keywords: liver biopsy, endoscopic ultrasound guided liver biopsy, FNA, FNB
Medical subject headings: Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

19-gauge FNA needleDevice
A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
19-gauge FNB needleDevice
A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.

Study groups in NCT03408171
Study group	Role	What they receive
19-gauge FNA needle	Active comparator	A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle. Receives: Device: 19-gauge FNA needle
19-gauge FNB needle	Active comparator	A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle. Receives: Device: 19-gauge FNB needle

What is being measured

The primary outcome is the main question the study is designed to answer.

Pre-processing Length of the Longest Piece (LLP)
Pre-processing Length of the longest piece (LLP) measured in centimeter
Measured: up to 5 days

Secondary outcomes (10)

Post-processing Length of the Longest Piece (LLP)
Post-processing Length of the longest piece (LLP) measured in centimeter
Measured: 3-5 days
Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm
Pre-processing Length of the longest piece (LLP) subgroups:
< 2 cm > 2cm
Measured: 3-5 days
Pre-processing Aggregate Specimen Length (ASL)
Pre-processing Aggregate specimen length (ASL) measured in centimeter
Measured: 3-5 days
Post-processing Aggregate Specimen Length (ASL)
Post-processing Aggregate specimen length (ASL) measured in centimeter
Measured: 3-5 days
Portal Triads Number (Mean)
Number of portal triads (PT) in the specimen.
Measured: 3-5 days
Portal Triads Quantity (Median)
Number of portal triads (PT) in the specimen.
Measured: 3-5 days
Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads
Portal triads groups, n (%) < 11 Portal triads > 11 Portal triads
Measured: 3-5 days
No. of Fragments > 9 mm, Mean (SD)
No. of fragments > 9 mm, mean (SD) Pre-processing Post-processing
Measured: 3-5 days
Specimen Quality for Histologic Diagnosis
Number of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle.
Measured: 3-5 days
Length of Longest Piece
Measured: Number Analyzed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Oct 201717 Aug 2018

First posted23 Jan 2018
Study start2 Oct 2017
Primary completion17 Aug 2018
Study completion17 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (27)Papers the sponsor has linked to this study.
Other trials for Abnormal Liver FunctionStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants are assigned to one of two groups for the duration of the study.
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03408171
Sponsor's protocol ID: 2017-0391
Status last verified: Apr 2020
First submitted: 6 Dec 2017
Last updated: 14 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Rockey DC, Caldwell SH, Goodman ZD, Nelson RC, Smith AD; American Association for the Study of Liver Diseases. Liver biopsy. Hepatology. 2009 Mar;49(3):1017-44. doi: 10.1002/hep.22742. No abstract available.
PubMed 19243014
Rockey DC, Bissell DM. Noninvasive measures of liver fibrosis. Hepatology. 2006 Feb;43(2 Suppl 1):S113-20. doi: 10.1002/hep.21046.
PubMed 16447288
Ziol M, Handra-Luca A, Kettaneh A, Christidis C, Mal F, Kazemi F, de Ledinghen V, Marcellin P, Dhumeaux D, Trinchet JC, Beaugrand M. Noninvasive assessment of liver fibrosis by measurement of stiffness in patients with chronic hepatitis C. Hepatology. 2005 Jan;41(1):48-54. doi: 10.1002/hep.20506.
PubMed 15690481
Sherlock S, Dick R, Van Leeuwen DJ. Liver biopsy today. The Royal Free Hospital experience. J Hepatol. 1985;1(1):75-85. doi: 10.1016/s0168-8278(85)80070-2.
PubMed 3902951
Eisenberg E, Konopniki M, Veitsman E, Kramskay R, Gaitini D, Baruch Y. Prevalence and characteristics of pain induced by percutaneous liver biopsy. Anesth Analg. 2003 May;96(5):1392-1396. doi: 10.1213/01.ANE.0000060453.74744.17.
PubMed 12707140
Firpi RJ, Soldevila-Pico C, Abdelmalek MF, Morelli G, Judah J, Nelson DR. Short recovery time after percutaneous liver biopsy: should we change our current practices? Clin Gastroenterol Hepatol. 2005 Sep;3(9):926-9. doi: 10.1016/s1542-3565(05)00294-6.
PubMed 16234032
Stone MA, Mayberry JF. An audit of ultrasound guided liver biopsies: a need for evidence-based practice. Hepatogastroenterology. 1996 Mar-Apr;43(8):432-4.
PubMed 8714240
McGill DB, Rakela J, Zinsmeister AR, Ott BJ. A 21-year experience with major hemorrhage after percutaneous liver biopsy. Gastroenterology. 1990 Nov;99(5):1396-400. doi: 10.1016/0016-5085(90)91167-5.
PubMed 2101588
Janes CH, Lindor KD. Outcome of patients hospitalized for complications after outpatient liver biopsy. Ann Intern Med. 1993 Jan 15;118(2):96-8. doi: 10.7326/0003-4819-118-2-199301150-00003.
PubMed 8416324
Huang JF, Hsieh MY, Dai CY, Hou NJ, Lee LP, Lin ZY, Chen SC, Wang LY, Hsieh MY, Chang WY, Yu ML, Chuang WL. The incidence and risks of liver biopsy in non-cirrhotic patients: An evaluation of 3806 biopsies. Gut. 2007 May;56(5):736-7. doi: 10.1136/gut.2006.115410. No abstract available.
PubMed 17440193
Bravo AA, Sheth SG, Chopra S. Liver biopsy. N Engl J Med. 2001 Feb 15;344(7):495-500. doi: 10.1056/NEJM200102153440706. No abstract available.
PubMed 11172192
Bull HJ, Gilmore IT, Bradley RD, Marigold JH, Thompson RP. Experience with transjugular liver biopsy. Gut. 1983 Nov;24(11):1057-60. doi: 10.1136/gut.24.11.1057.
PubMed 6629116
Poniachik J, Bernstein DE, Reddy KR, Jeffers LJ, Coelho-Little ME, Civantos F, Schiff ER. The role of laparoscopy in the diagnosis of cirrhosis. Gastrointest Endosc. 1996 Jun;43(6):568-71. doi: 10.1016/s0016-5107(96)70192-x.
PubMed 8781934
Denzer U, Arnoldy A, Kanzler S, Galle PR, Dienes HP, Lohse AW. Prospective randomized comparison of minilaparoscopy and percutaneous liver biopsy: diagnosis of cirrhosis and complications. J Clin Gastroenterol. 2007 Jan;41(1):103-10. doi: 10.1097/01.mcg.0000225612.86846.82.
PubMed 17198072
Diehl DL, Johal AS, Khara HS, Stavropoulos SN, Al-Haddad M, Ramesh J, Varadarajulu S, Aslanian H, Gordon SR, Shieh FK, Pineda-Bonilla JJ, Dunkelberger T, Gondim DD, Chen EZ. Endoscopic ultrasound-guided liver biopsy: a multicenter experience. Endosc Int Open. 2015 Jun;3(3):E210-5. doi: 10.1055/s-0034-1391412. Epub 2015 Feb 27.
PubMed 26171433

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 19-Gauge Fine Needle Aspirate (FNA) Versus 19-Gauge Fine Needle Biopsy (FNB) Needles for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Randomized Prospective Trial
ClinicalTrials.gov ID: NCT03408171
Acronym / sponsor ID: 2017-0391
Conditions: Abnormal Liver Function
Keywords: liver biopsy, endoscopic ultrasound guided liver biopsy, FNA, FNB
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Geisinger ClinicUniversity, hospital or other
Study start: 2 Oct 2017 (actual)
Primary completion: 17 Aug 2018 (actual)
Study completion: 17 Aug 2018 (actual)
First posted: 23 Jan 2018 (actual)
Results: Posted 14 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants are assigned to one of two groups for the duration of the study.

Arm	Type	Receives
19-gauge FNA needle	Active comparator	Device: 19-gauge FNA needleA 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
19-gauge FNB needle	Active comparator	Device: 19-gauge FNB needleA 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.

Who may qualify

Ages: 18 years and older
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
Non-pregnant patients

Key exclusion criteria (9 listed)

Age < 18 years
Pregnant patients
Inability to obtain consent
Anticoagulants or anti-platelet agents use (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
19-gauge FNA needleA 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.	Device	19-gauge FNA needle
19-gauge FNB needleA 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.	Device	19-gauge FNB needle

Primary outcome

Pre-processing Length of the Longest Piece (LLP)
Time frame: up to 5 days
Pre-processing Length of the longest piece (LLP) measured in centimeter

10 secondary outcomes

Post-processing Length of the Longest Piece (LLP)
Time frame: 3-5 days
Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm
Time frame: 3-5 days
Pre-processing Aggregate Specimen Length (ASL)
Time frame: 3-5 days
Post-processing Aggregate Specimen Length (ASL)
Time frame: 3-5 days
Portal Triads Number (Mean)
Time frame: 3-5 days
Portal Triads Quantity (Median)
Time frame: 3-5 days
Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads
Time frame: 3-5 days
No. of Fragments > 9 mm, Mean (SD)
Time frame: 3-5 days
Specimen Quality for Histologic Diagnosis
Time frame: 3-5 days
Length of Longest Piece
Time frame: Number Analyzed

Results and safety

Results posted to the registry on 14 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
19-gauge FNA Needle	20	20
19-gauge FNB Needle	20	20

Primary outcome: Pre-processing Length of the Longest Piece (LLP)

Time frame: up to 5 days. Mean (Standard Deviation). Unit: centimeter

Measure	19-gauge FNA Needle n = 20	19-gauge FNB Needle n = 20
Value	1.47 (0.46)	2.09 (0.41)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
19-gauge FNA Needle	0 of 20 (0%)	8 of 20 (40%)	0 of 20
19-gauge FNB Needle	0 of 20 (0%)	7 of 20 (35%)	0 of 20

Limitations and caveats (from the sponsor): Research was completed at a high-volume center; therefore, our outcomes may not be fully applicable to small practices. Learning curve to achieving best possible tissue samples with EUS-LB, which appears to be between 10 and 20 procedures.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19243014Rockey DC, Caldwell SH, Goodman ZD, Nelson RC, Smith AD; American Association for the Study of Liver Diseases. Liver biopsy. Hepatology. 2009 Mar;49(3):1017-44. doi: 10.1002/hep.22742. No abstract available.
Background: PubMed 16447288Rockey DC, Bissell DM. Noninvasive measures of liver fibrosis. Hepatology. 2006 Feb;43(2 Suppl 1):S113-20. doi: 10.1002/hep.21046.
Background: PubMed 15690481Ziol M, Handra-Luca A, Kettaneh A, Christidis C, Mal F, Kazemi F, de Ledinghen V, Marcellin P, Dhumeaux D, Trinchet JC, Beaugrand M. Noninvasive assessment of liver fibrosis by measurement of stiffness in patients with chronic hepatitis C. Hepatology. 2005 Jan;41(1):48-54. doi: 10.1002/hep.20506.
Background: PubMed 3902951Sherlock S, Dick R, Van Leeuwen DJ. Liver biopsy today. The Royal Free Hospital experience. J Hepatol. 1985;1(1):75-85. doi: 10.1016/s0168-8278(85)80070-2.
Background: PubMed 12707140Eisenberg E, Konopniki M, Veitsman E, Kramskay R, Gaitini D, Baruch Y. Prevalence and characteristics of pain induced by percutaneous liver biopsy. Anesth Analg. 2003 May;96(5):1392-1396. doi: 10.1213/01.ANE.0000060453.74744.17.
Background: PubMed 16234032Firpi RJ, Soldevila-Pico C, Abdelmalek MF, Morelli G, Judah J, Nelson DR. Short recovery time after percutaneous liver biopsy: should we change our current practices? Clin Gastroenterol Hepatol. 2005 Sep;3(9):926-9. doi: 10.1016/s1542-3565(05)00294-6.
Background: PubMed 8714240Stone MA, Mayberry JF. An audit of ultrasound guided liver biopsies: a need for evidence-based practice. Hepatogastroenterology. 1996 Mar-Apr;43(8):432-4.
Background: PubMed 2101588McGill DB, Rakela J, Zinsmeister AR, Ott BJ. A 21-year experience with major hemorrhage after percutaneous liver biopsy. Gastroenterology. 1990 Nov;99(5):1396-400. doi: 10.1016/0016-5085(90)91167-5.
Background: PubMed 8416324Janes CH, Lindor KD. Outcome of patients hospitalized for complications after outpatient liver biopsy. Ann Intern Med. 1993 Jan 15;118(2):96-8. doi: 10.7326/0003-4819-118-2-199301150-00003.
Background: PubMed 17440193Huang JF, Hsieh MY, Dai CY, Hou NJ, Lee LP, Lin ZY, Chen SC, Wang LY, Hsieh MY, Chang WY, Yu ML, Chuang WL. The incidence and risks of liver biopsy in non-cirrhotic patients: An evaluation of 3806 biopsies. Gut. 2007 May;56(5):736-7. doi: 10.1136/gut.2006.115410. No abstract available.
Background: PubMed 11172192Bravo AA, Sheth SG, Chopra S. Liver biopsy. N Engl J Med. 2001 Feb 15;344(7):495-500. doi: 10.1056/NEJM200102153440706. No abstract available.
Background: PubMed 6629116Bull HJ, Gilmore IT, Bradley RD, Marigold JH, Thompson RP. Experience with transjugular liver biopsy. Gut. 1983 Nov;24(11):1057-60. doi: 10.1136/gut.24.11.1057.

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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 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 19-gauge FNA needle and 19-gauge FNB needle in people with Abnormal Liver Function, 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 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: finished, as of the sponsor's last update on 14 Apr 2020. 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?

Yes. Results are posted in the registry (first posted 14 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pre-processing Length of the Longest Piece (LLP) (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 NCT03408171, which also lists 27 linked publications.

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 Apr 2020.