Liver DiseasesBLOCSNCT03245580

Benign Liver Optimal Core Study (Tissue Acquisition Comparison in Benign Liver Disease)

A study testing Core Liver Biopsy in people with Liver Diseases, run by Parkview Health at 7 sites in United States.

Completed

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

Trial summary

The primary purpose of this prospective, randomized, multicenter study is to evaluate and compare the amount and quality of tissue samples yielded in a liver biopsy comparing 2 different techniques of EUS guided CORE liver biopsy for benign disease. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Liver Diseases
What is being tested?: Core Liver Biopsy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 153 participants
Where: 7 sitesUnited States
Study dates: 8 Mar 2018to 15 Sep 2020
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

Subjects that plan to undergo a liver biopsy via EUS to confirm possible underlying liver disease or to determine stage, grade and presence of fibrosis for suspected benign etiology.
History of abnormal LFTs
Documented history of chronic liver disease
Question of underlying liver disease as cause of abnormal imaging or symptoms which may be attributed to liver disorder
Fatty liver disease
Subjects 18 years of age or older

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Subject must be able to hold anticoagulants as per institutional standard of care
Subjects must be deemed physically able to undergo anesthesia. This includes either Monitored Anesthesia Care (MAC) or general anesthesia.
Subjects (or the subjects Legally Authorized Representative [LAR]) that have agreed to participate in the study and have signed Informed Consent
Women of child bearing potential who are not pregnant as proven by a negative pregnancy test may be included.

Who cannot join

Subjects that are unable to tolerate anesthesia for the procedure
Subjects 17 or under
Subjects whose anticoagulants cannot be held
Subjects who cannot have or refuse EUS guided procedure
Subjects who are pregnant
INR >1.5

Show all 11Show fewer

Platelets 50,000 or less
Subjects requiring control of bleeding on initial upper endoscopy
Subjects requiring endoscopic mucosal resection
Subjects with large volume ascites
Subjects requiring pancreatic biopsies

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Geisinger Medical Center
Danville, Pennsylvania, 17822
Parkview Regional Medical Center
Fort Wayne, Indiana, 46845
Baylor Medical Center
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University South Alabama
Mobile, Alabama, 36608
Oschner Health System
New Orleans, Louisiana, 70121
Santa CLara Valley Medical Center
San Jose, California, 95128

Other trials in United States

About this study

Official title: Comparison of 2 Techniques Using EUS Guided Liver Biopsies Via 19g CORE Biopsy Needle to Obtain Optimal Core Liver Biopsies in Benign Disease

Read the detailed description

Each subject will have a biopsy performed via one of 2 different techniques: "modified wet suction", or "slow pull" technique. A randomization process will determine which technique. Each subject shall undergo 2 passes (2 cores of tissue will be obtained - ideally from the right and left lobe of the liver.

Quality of tissue obtained via the 2 different techniques will be evaluated by number of fragments, length of specimens and number of tracts observed by the local pathologist and compared between the tissues obtained from the two techniques. .

Conditions: Liver Diseases
Being tested: Core Liver Biopsy
Medical subject headings: Liver Diseases

What participants receive

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

Core Liver BiopsyDiagnostic test
Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.

Study groups in NCT03245580
Study group	Role	What they receive
Arm 1 -modified wet suction	Other	Intervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction Receives: Diagnostic Test: Core Liver Biopsy
Arm 2- Slow Pull	Other	Intervention: Procedure Core Liver Biopsy Technique: Slow Pull Receives: Diagnostic Test: Core Liver Biopsy

What is being measured

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

Pathological Yield Fragmentation
To determine if there is a significant difference in pathological yield as determined by fragmentation of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. Pathological yield will be measured by assessment of portal tracts fragmentation by designated pathologists with experience in liver biopsy specimens.
Measured: At day 7 post biopsy
Pathological Yield Length
To determine if there is a significant difference in pathological yield as determined by length of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. Length of portal tracts will be measured in mm by designated pathologists with experience in liver biopsy assessment techniques.
Measured: At time of completion of pathology report
Pathological Yield Quantity
To determine if there is a significant difference in pathological yield as determined by number of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. The number of portal tracts will be assesses and tallied by designated pathologists with experience in the assessment of liver biopsies.
Measured: At time of completion of pathology report

Secondary outcomes (1)

Complications
Tracking any complications that may be associated with each technique. Complications will be assessed and tracked following CTCAE V4.
Measured: Complications occurring at time of consent, at procedure time and at day 7 post procedure

Timeline

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

8 Mar 201815 Sep 2020

First posted10 Aug 2017
Study start8 Mar 2018
Primary completion15 Sep 2020
Study completion15 Sep 2020

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.
Other trials for Liver DiseasesStudies 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: prospective, randomized, multicenter study
Masking: None (open label)
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03245580
Sponsor's protocol ID: PRC17-0714
Acronym: BLOCS
Status last verified: Mar 2022
First submitted: 17 Jul 2017
Last updated: 7 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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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Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of 2 Techniques Using EUS Guided Liver Biopsies Via 19g CORE Biopsy Needle to Obtain Optimal Core Liver Biopsies in Benign Disease
ClinicalTrials.gov ID: NCT03245580
Acronym / sponsor ID: BLOCS / PRC17-0714
Conditions: Liver Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Parkview HealthUniversity, hospital or other
Study start: 8 Mar 2018 (actual)
Primary completion: 15 Sep 2020 (actual)
Study completion: 15 Sep 2020 (actual)
First posted: 10 Aug 2017 (actual)
Results: Posted 7 Apr 2022

Clinical summary

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

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: prospective, randomized, multicenter study

Arm	Type	Receives
Arm 1 -modified wet suction	Other	Diagnostic Test: Core Liver BiopsyIntervention:Procedure Core Liver Biopsy Technique: Modified Wet Suction
Arm 2- Slow Pull	Other	Diagnostic Test: Core Liver BiopsyIntervention: Procedure Core Liver Biopsy Technique: Slow Pull

Who may qualify

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

Key inclusion criteria (10 listed)

Subjects that plan to undergo a liver biopsy via EUS to confirm possible underlying liver disease or to determine stage, grade and presence of fibrosis for suspected benign etiology.
History of abnormal LFTs
Documented history of chronic liver disease
Question of underlying liver disease as cause of abnormal imaging or symptoms which may be attributed to liver disorder
Fatty liver disease

Key exclusion criteria (11 listed)

Subjects that are unable to tolerate anesthesia for the procedure
Subjects 17 or under
Subjects whose anticoagulants cannot be held
Subjects who cannot have or refuse EUS guided procedure
Subjects who are pregnant

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
Core Liver BiopsyDiagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.	Diagnostic test	Arm 1 -modified wet suction, Arm 2- Slow Pull

Primary outcome

Pathological Yield Fragmentation
Time frame: At day 7 post biopsy
To determine if there is a significant difference in pathological yield as determined by fragmentation of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. Pathological yield will be measured by assessment of portal tracts fragmentation by designated pathologists with experience in liver biopsy specimens.
Pathological Yield Length
Time frame: At time of completion of pathology report
To determine if there is a significant difference in pathological yield as determined by length of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. Length of portal tracts will be measured in mm by designated pathologists with experience in liver biopsy assessment techniques.
Pathological Yield Quantity
Time frame: At time of completion of pathology report
To determine if there is a significant difference in pathological yield as determined by number of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. The number of portal tracts will be assesses and tallied by designated pathologists with experience in the assessment of liver biopsies.

1 secondary outcome

Complications
Time frame: Complications occurring at time of consent, at procedure time and at day 7 post procedure

Results and safety

Results posted to the registry on 7 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1 -Modified Wet Suction	75	75
Arm 2- Slow Pull	78	78

Primary outcome: Pathological Yield Fragmentation

Time frame: At day 7 post biopsy. Mean (Full Range). Unit: mm

Measure	Arm 1 -Modified Wet Suction n = 75	Arm 2- Slow Pull n = 78
Length of Longest Fragment- Left Lobe	14 (11 to 20)	11 (6 to 15)
Length of Longest Fragment- Right Lobe	13 (9 to 19)	10 (8 to 15)

Primary outcome: Pathological Yield Length

Time frame: At time of completion of pathology report. Mean (Full Range). Unit: mm

Measure	Arm 1 -Modified Wet Suction n = 75	Arm 2- Slow Pull n = 78
Total Length of Fragments - Left Lobe	46.5 (31 to 71)	34.5 (17 to 42)
Total Length of Fragments-Right Lobe	38 (22 to 60)	28 (17 to 40)

Primary outcome: Pathological Yield Quantity

Time frame: At time of completion of pathology report. Mean (Full Range). Unit: Number of portal tracts

Measure	Arm 1 -Modified Wet Suction n = 75	Arm 2- Slow Pull n = 78
Total Number of Portal Tracts Left Lobe	16 (12 to 24.5)	11.5 (6.5 to 18.5)
Total Number of Portal Tracts Right Lobe	14 (10 to 18)	12 (7 to 17)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Data collected for one week following procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1 -Modified Wet Suction	7 of 75 (9.3%)	13 of 75 (17.3%)	0 of 75
Arm 2- Slow Pull	2 of 78 (2.6%)	10 of 78 (12.8%)	0 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Liver Diseases

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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.

Neil R Sharma, MD principal investigator

parkview cancer institute

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

Questions about this trial

What is this clinical trial studying?

A study testing Core Liver Biopsy in people with Liver Diseases, run by Parkview Health at 7 sites 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 10 inclusion and 11 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 7 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 7 sites 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 7 Apr 2022). 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?

Pathological Yield Fragmentation (time frame: At day 7 post biopsy). 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?

On the ClinicalTrials.gov record for NCT03245580.

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 7 Apr 2022; AzTrials last refreshed its copy on 30 Oct 2026.