Liver BiopsyNCT04003766

Endoscopic Ultrasound vs Percutaneous Route for Liver Biopsy

A study testing biopsy in people with Liver Biopsy, run by AdventHealth at 1 site in United States.

Completed

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

Trial summary

This study is to evaluate and directly compare the technical success, tissue quality, diagnostic efficacy and safety profile of Percutaneous and Endoscopic Ultrasound-guided Liver Biopsy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Liver Biopsy
What is being tested?: biopsy
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 25 Jul 2019to 11 Feb 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients referred for liver biopsy for any reason
Informed consent obtained from the patient
≥ 18 years old
Able to undergo conscious sedation for EUS procedure

Who cannot join

<18 years old
Unable to obtain informed consent from the patient
Medically unfit for sedation
Pregnant patients
Presence of a mass lesion in the liver requiring biopsy visualized on cross-sectional imaging
Irreversible coagulopathy as determined by platelet count < 50,000 mm3 or International Normalized Ratio (INR) > 1.5

Show all 9Show fewer

Unable to stop anticoagulation or anti-platelet therapy for 5 days prior to the procedure
Hemophilia
Presence of an alternative etiology for elevated liver tests seen during liver biopsy, e.g. choledocholithiasis discovered during EUS examination

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Interventional Endoscopy
Orlando, Florida, 32803

Other trials in United States

About this study

Official title: Randomized Trial Comparing Endoscopic Ultrasound-guided Liver Biopsy vs. Percutaneous Liver Biopsy

This study is to evaluate and directly compare the technical success, tissue quality, diagnostic efficacy and safety profile of Percutaneous and Endoscopic Ultrasound-guided Liver Biopsy.

Read the detailed description

Liver biopsy (LB) is essential for the diagnosis and evaluation of a variety of hepatic conditions, such as grading/staging of chronic liver disease secondary to alcohol, non-alcoholic steatohepatitis, viral hepatitis, hemochromatosis, Wilson's disease, cholestatic liver disease, as well as in elucidating the etiology of elevation in liver tests.1 Since it was first performed in 1883, percutaneous (PC) liver biopsy has become routine practice and is usually performed under the guidance of real-time imaging using transabdominal ultrasound (US) or computed tomography (CT).1,2 However, in recent times, liver biopsy has been increasingly performed via transgastric or transduodenal routes under endoscopic ultrasound (EUS) guidance. The perceived advantages of performing EUS-LB compared to PC-LB are the ability to simultaneously assess other organs such as common bile duct and pancreas, access to both left and right lobes of the liver and the routine use of conscious sedation during EUS procedures.3 Although single arm cohort studies and retrospective comparative studies assessing the technical success, tissue quality and safety of these different liver biopsy modalities exist, currently there are no randomized trials comparing PC and EUS-guided LB.4-7

Conditions: Liver Biopsy
Being tested: biopsy
Keywords: percutaneous biopsy, endoscopic guided biopsy, liver, hepatic conditions

What participants receive

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

biopsyDiagnostic test
Liver biopsy (LB) is essential for the diagnosis and evaluation of a variety of hepatic conditions, such as grading/staging of chronic liver disease secondary to alcohol, non-alcoholic steatohepatitis, viral hepatitis, hemochromatosis, Wilson's disease, cholestatic liver disease, as well as in elucidating the etiology of elevation in liver tests.

Study groups in NCT04003766
Study group	Role	What they receive
Percutaneous Biopsy	Active comparator	The subject would undergo the standard of care procedure for a percutaneous biopsy of the liver. All percutaneous biopsies will be performed after administration of local anesthetic. No pre-procedure antibiotics will be administered. Subcostal or subxyphoid area will be cleaned and draped in the standard manner. 2% lidocaine solution will be injected subcutaneously using a 25-gauge needle and then administered into the subcutaneous tissue up to the liver capsule. A 16-gauge biopsy needle is inserted into the liver parenchyma under US or CT-guidance, with the location of needle placement left to the discretion of the performing radiologist. One or two core biopsy samples will be obtained. All procured specimens will be placed in a single specimen container of 10% formalin for tissue processing. When biopsy samples have been obtained, the patient will be taken to the recovery area for post-procedure monitoring. Receives: Diagnostic Test: biopsy
Endoscopic-guided Ultrasound Biopsy	Active comparator	The subject would undergo the standard of care procedure for an endoscopic-guided biopsy of the liver. The left lobe of the liver is identified from the gastric lumen, EUS-guided fine needle biopsy (FNB) will be performed using a 19-gauge FNB needle, with the choice of needle type at the discretion of the performing endoscopist. Stylet will only be used to puncture the liver at the time of the first pass and then subsequently removed. No suction will be used. Fanning technique will not be used. A total of 10 to-and-fro needle movements will be performed during each pass. A total of two passes will be performed.All tissue specimens procured will be placed in a single specimen container of 10% formalin for tissue processing. When two passes are complete under EUS-guidance, the echoendoscope will be withdrawn from the patient and the patient will be taken to the recovery area for post-procedure monitoring. Receives: Diagnostic Test: biopsy

What is being measured

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

Diagnostic adequacy of the tissue sample
The primary outcome of the randomized trial is to compare between EUS-LB and PC-LB, the rate of procurement of diagnostically adequate specimens, defined as the presence of both maximum specimen length ≥ 25mm AND total no. of complete portal tracts ≥ 11.
Measured: 24 hours

Secondary outcomes (8)

Specimen length
Maximum specimen length in millimeters after formalin fixation will be documented.
Measured: 24 hours
Portal tracts
The total number of complete portal tracts for each biopsy specimen will be documented.
Measured: 24 hours
Rates of specimen adequacy
Inadequate specimen - defined as biopsy specimens from which a definitive histological diagnosis cannot be rendered by the pathologist.
Measured: 24 hours
Cross over
The rate of crossover to the other treatment arm will be documented
Measured: 1 week, 30 days
Procedure duration
The total length of time for the procedure will be documented in minutes.
Measured: 24 hours
Rate of adverse events
The subject will be asked to report and medical records will be reviewed for any adveerse events related to the procedure.
Measured: 24 hours, 1 week, 30 days
Procedural costs
The subject's account will be reviewed for total costs associated with the procedure.
Measured: 30 days
Pain scores
Pain scores measured using the Visual Analog Scale (VAS) on a scale of 0 - 10 with 0 representing no pain and 10 representing the worst pain the subject has ever had; before and after biopsy has been performed.
Measured: 24 hours, 1 week, 30 days

Timeline

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

25 Jul 201911 Feb 2022

First posted1 Jul 2019
Study start25 Jul 2019
Primary completion31 Dec 2020
Study completion11 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Liver BiopsyStudies 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 randomized trial comparing two methods for procuring liver biopsy: 1) EUS-guided and 2) percutaneous.
Masking: Single blind
Who is masked: Care provider
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04003766
Sponsor's protocol ID: 1438608
Status last verified: Feb 2022
First submitted: 5 Jun 2019
Last updated: 24 Feb 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: There is no plan to share IPD.

Publications

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
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
Diehl DL. Endoscopic Ultrasound-guided Liver Biopsy. Gastrointest Endosc Clin N Am. 2019 Apr;29(2):173-186. doi: 10.1016/j.giec.2018.11.002. Epub 2019 Feb 2.
PubMed 30846147
Pineda JJ, Diehl DL, Miao CL, Johal AS, Khara HS, Bhanushali A, Chen EZ. EUS-guided liver biopsy provides diagnostic samples comparable with those via the percutaneous or transjugular route. Gastrointest Endosc. 2016 Feb;83(2):360-5. doi: 10.1016/j.gie.2015.08.025. Epub 2015 Aug 22.
PubMed 26301407
Tublin ME, Blair R, Martin J, Malik S, Ruppert K, Demetris A. Prospective Study of the Impact of Liver Biopsy Core Size on Specimen Adequacy and Procedural Complications. AJR Am J Roentgenol. 2018 Jan;210(1):183-188. doi: 10.2214/AJR.17.17792. Epub 2017 Nov 1.
PubMed 29091001
Hall TC, Deakin C, Atwal GS, Singh RK. Adequacy of percutaneous non-targeted liver biopsy under real-time ultrasound guidance when comparing the Biopince and Achieve biopsy needle. Br J Radiol. 2017 Dec;90(1080):20170397. doi: 10.1259/bjr.20170397. Epub 2017 Oct 3.
PubMed 28972801
Mohan BP, Shakhatreh M, Garg R, Ponnada S, Adler DG. Efficacy and safety of EUS-guided liver biopsy: a systematic review and meta-analysis. Gastrointest Endosc. 2019 Feb;89(2):238-246.e3. doi: 10.1016/j.gie.2018.10.018. Epub 2018 Oct 31.
PubMed 30389469
Wyatt J, Hubscher S, Bellamy C. Tissue pathways for liver biopsies for the investigation of medical disease and for focal lesions. London, UK: The Royal College of Pathologists; 2014.

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?

See locations

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All Liver Biopsy trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial Comparing Endoscopic Ultrasound-guided Liver Biopsy vs. Percutaneous Liver Biopsy
ClinicalTrials.gov ID: NCT04003766
Acronym / sponsor ID: 1438608
Conditions: Liver Biopsy
Keywords: percutaneous biopsy, endoscopic guided biopsy, liver, hepatic conditions
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: AdventHealthUniversity, hospital or other
Study start: 25 Jul 2019 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 11 Feb 2022 (actual)
First posted: 1 Jul 2019 (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.

This study is to evaluate and directly compare the technical success, tissue quality, diagnostic efficacy and safety profile of Percutaneous and Endoscopic Ultrasound-guided Liver Biopsy.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 2
Model description: This is a randomized trial comparing two methods for procuring liver biopsy: 1) EUS-guided and 2) percutaneous.

Arm	Type	Receives
Percutaneous Biopsy	Active comparator	Diagnostic Test: biopsyThe subject would undergo the standard of care procedure for a percutaneous biopsy of the liver. All percutaneous biopsies will be performed after administration of local anesthetic. No pre-procedure antibiotics will be administered. Subcostal or subxyphoid area will be cleaned and draped in the standard manner. 2% lidocaine solution will be injected subcutaneously using a 25-gauge needle and then administered into the subcutaneous tissue up to the liver capsule. A 16-gauge biopsy needle is inserted into the liver parenchyma under US or CT-guidance, with the location of needle placement left to the discretion of the performing radiologist. One or two core biopsy samples will be obtained. All procured specimens will be placed in a single specimen container of 10% formalin for tissue processing. When biopsy samples have been obtained, the patient will be taken to the recovery area for post-procedure monitoring.
Endoscopic-guided Ultrasound Biopsy	Active comparator	Diagnostic Test: biopsyThe subject would undergo the standard of care procedure for an endoscopic-guided biopsy of the liver. The left lobe of the liver is identified from the gastric lumen, EUS-guided fine needle biopsy (FNB) will be performed using a 19-gauge FNB needle, with the choice of needle type at the discretion of the performing endoscopist. Stylet will only be used to puncture the liver at the time of the first pass and then subsequently removed. No suction will be used. Fanning technique will not be used. A total of 10 to-and-fro needle movements will be performed during each pass. A total of two passes will be performed.All tissue specimens procured will be placed in a single specimen container of 10% formalin for tissue processing. When two passes are complete under EUS-guidance, the echoendoscope will be withdrawn from the patient and the patient will be taken to the recovery area for post-procedure monitoring.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

All patients referred for liver biopsy for any reason
Informed consent obtained from the patient
≥ 18 years old
Able to undergo conscious sedation for EUS procedure

Key exclusion criteria (9 listed)

<18 years old
Unable to obtain informed consent from the patient
Medically unfit for sedation
Pregnant patients
Presence of a mass lesion in the liver requiring biopsy visualized on cross-sectional imaging

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
biopsyLiver biopsy (LB) is essential for the diagnosis and evaluation of a variety of hepatic conditions, such as grading/staging of chronic liver disease secondary to alcohol, non-alcoholic steatohepatitis, viral hepatitis, hemochromatosis, Wilson's disease, cholestatic liver disease, as well as in elucidating the etiology of elevation in liver tests.	Diagnostic test	Endoscopic-guided Ultrasound Biopsy, Percutaneous Biopsy

Primary outcome

Diagnostic adequacy of the tissue sample
Time frame: 24 hours
The primary outcome of the randomized trial is to compare between EUS-LB and PC-LB, the rate of procurement of diagnostically adequate specimens, defined as the presence of both maximum specimen length ≥ 25mm AND total no. of complete portal tracts ≥ 11.

8 secondary outcomes

Specimen length
Time frame: 24 hours
Portal tracts
Time frame: 24 hours
Rates of specimen adequacy
Time frame: 24 hours
Cross over
Time frame: 1 week, 30 days
Procedure duration
Time frame: 24 hours
Rate of adverse events
Time frame: 24 hours, 1 week, 30 days
Procedural costs
Time frame: 30 days
Pain scores
Time frame: 24 hours, 1 week, 30 days

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 24 Feb 2022.
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 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 30846147Diehl DL. Endoscopic Ultrasound-guided Liver Biopsy. Gastrointest Endosc Clin N Am. 2019 Apr;29(2):173-186. doi: 10.1016/j.giec.2018.11.002. Epub 2019 Feb 2.
Background: PubMed 26301407Pineda JJ, Diehl DL, Miao CL, Johal AS, Khara HS, Bhanushali A, Chen EZ. EUS-guided liver biopsy provides diagnostic samples comparable with those via the percutaneous or transjugular route. Gastrointest Endosc. 2016 Feb;83(2):360-5. doi: 10.1016/j.gie.2015.08.025. Epub 2015 Aug 22.
Background: PubMed 29091001Tublin ME, Blair R, Martin J, Malik S, Ruppert K, Demetris A. Prospective Study of the Impact of Liver Biopsy Core Size on Specimen Adequacy and Procedural Complications. AJR Am J Roentgenol. 2018 Jan;210(1):183-188. doi: 10.2214/AJR.17.17792. Epub 2017 Nov 1.
Background: PubMed 28972801Hall TC, Deakin C, Atwal GS, Singh RK. Adequacy of percutaneous non-targeted liver biopsy under real-time ultrasound guidance when comparing the Biopince and Achieve biopsy needle. Br J Radiol. 2017 Dec;90(1080):20170397. doi: 10.1259/bjr.20170397. Epub 2017 Oct 3.
Background: PubMed 30389469Mohan BP, Shakhatreh M, Garg R, Ponnada S, Adler DG. Efficacy and safety of EUS-guided liver biopsy: a systematic review and meta-analysis. Gastrointest Endosc. 2019 Feb;89(2):238-246.e3. doi: 10.1016/j.gie.2018.10.018. Epub 2018 Oct 31.
BackgroundWyatt J, Hubscher S, Bellamy C. Tissue pathways for liver biopsies for the investigation of medical disease and for focal lesions. London, UK: The Royal College of Pathologists; 2014.
Individual participant dataSharing planned: No. There is no plan to share IPD.

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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.

Muhammad Hasan, MD principal investigator

AdventHealth

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing biopsy in people with Liver Biopsy, run by AdventHealth 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 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: finished, as of the sponsor's last update on 24 Feb 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?

Diagnostic adequacy of the tissue sample (time frame: 24 hours). 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 NCT04003766, which also lists 8 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 24 Feb 2022.