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Liver CirrhosisEUS-PERCNCT07701031

Assessing EUS and Percutaneous Untargeted Liver Biopsy Quality

An observational study of Liver Cirrhosis and Liver Disease Chronic, run by University Hospital Muenster at 1 site in Germany.

Completed

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

Official record
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Trial summary

This prospective, single-center study evaluates and compares the tissue sample quality and patient comfort of different liver biopsy methods. While traditional percutaneous liver biopsy passes a needle through the abdominal wall into the liver, endoscopic ultrasound-guided liver biopsy (EUS-LB) offers an internal… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
EUS Liver biopsy 19G FNA, EUS LB 19G FNB and EUS LB 22G FNB
How many people
146 participants
Where
1 siteGermany
Study dates
1 Jan 2023to 15 Nov 2024
Phase
Observational
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

Study population: All consecutive adult patients undergoing clinically indicated untargeted liver biopsy during the study period at our tertiary liver center.

Who may be able to join

  • clinical indication for non-targeted liver biopsy
  • written informed consent

Who cannot join

  • ascites
  • severe coagulopathy (INR >2.0 or platelet count <50 × 10³/µl)
  • contraindications to endoscopy or sedation
  • anatomical conditions precluding safe liver biopsy
  • pregnancy

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Muenster

    Münster, 48149

Other trials in Germany

About this study

Official title: Assessing EUS and Percutaneous Untargeted Liver Biopsy Quality: A Sequential-Period Cluster-Randomized Study

This prospective, single-center study evaluates and compares the tissue sample quality and patient comfort of different liver biopsy methods. While traditional percutaneous liver biopsy passes a needle through the abdominal wall into the liver, endoscopic ultrasound-guided liver biopsy (EUS-LB) offers an internal alternative performed via the stomach under sedation. However, the optimal EUS needle size and tip design remain unclear. Therefore, this trial directly compares the diagnostic tissue yield and patient-reported pain across four contemporary EUS needle strategies and the traditional percutaneous approach. The study utilizes a sequential-period cluster-randomized design, enrolling consecutive adult patients who require a clinically indicated, untargeted liver biopsy over five predefined, sequential eight-week periods. Each eight-week block serves as a cluster, during which all enrolled patients receive the specific biopsy needle assigned to that period. The trial begins with the standard percutaneous 18G TruCut needle cluster. To minimize bias, the sequence of the subsequent four EUS-guided needle clusters-consisting of 19G FNA, 19G FNB, 22G FNA, and 22G FNB needles-is determined beforehand using a computer-generated random sequence. All procedures are performed by the same clinical team using highly standardized techniques to compare total specimen length, complete portal tracts, and procedure-associated pain across all groups.

Being tested
EUS Liver biopsy 19G FNA, EUS LB 19G FNB, EUS LB 22G FNB, EUS LB 22G FNA, PC-LB 18G Trucut
Keywords
Endoscopic ultrasound, EUS, Liver biopsy
Medical subject headings
Liver Cirrhosis

What participants receive

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

  • EUS Liver biopsy 19G FNADiagnostic test

    Liver biopsy performed with 19G FNA

  • EUS LB 19G FNBDiagnostic test

    Liver biopsy performed with 19G FNB

  • EUS LB 22G FNBDiagnostic test

    Liver biopsy performed with 22G FNB

  • EUS LB 22G FNADiagnostic test

    Liver biopsy performed with 22G FNA

  • PC-LB 18G TrucutDiagnostic test

    Percutaneous Liver biopsy 18G Trucut

Study groups in NCT07701031
Study groupRoleWhat they receive
Percutaneous Liver Biopsy 18G TrucutNot described
Receives: Diagnostic Test: PC-LB 18G Trucut
EUS-LB 19G FNANot described
Receives: Diagnostic Test: EUS Liver biopsy 19G FNA
EUS-LB 19G FNBNot described
Receives: Diagnostic Test: EUS LB 19G FNB
EUS-LB 22G FNANot described
Receives: Diagnostic Test: EUS LB 22G FNA
EUS-LB 22G FNBNot described
Receives: Diagnostic Test: EUS LB 22G FNB

What is being measured

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

  1. Biopsy specimen length

    Measured: From enrollment within one week

  2. Number of complete portal tracts

    Measured: From enrollment within one week

Secondary outcomes (3)

  1. Overall adequacy

    Specimen length ≥ 15 mm

    Measured: 7 days (until pathologic examination finished)

  2. Adverse events

    Bleeding and pain

    Measured: 72 hours

  3. Number of complete portal tracts ≥ 11

    Measured: 7 days (until pathologic examination finished)

Timeline

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

  1. First posted14 Jul 2026
  2. Study start1 Jan 2023
  3. Primary completion1 Nov 2024
  4. Study completion15 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07701031
Sponsor's protocol ID
MSLB2
Acronym
EUS-PERC
Status last verified
Jul 2026
First submitted
8 Jul 2026
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hajifathalian K, Westerveld D, Kaplan A, Dawod E, Herr A, Ianelli M, Saggese A, Kumar S, Fortune BE, Sharaiha RZ. Simultaneous EUS-guided portosystemic pressure measurement and liver biopsy sampling correlate with clinically meaningful outcomes. Gastrointest Endosc. 2022 Apr;95(4):703-710. doi: 10.1016/j.gie.2021.11.037. Epub 2021 Dec 7.

    PubMed 34890694

  • Bang JY, Ward TJ, Guirguis S, Krall K, Contreras F, Jhala N, Navaneethan U, Hawes RH, Varadarajulu S. Radiology-guided percutaneous approach is superior to EUS for performing liver biopsies. Gut. 2021 Dec;70(12):2224-2226. doi: 10.1136/gutjnl-2021-324495. Epub 2021 Mar 25. No abstract available.

    PubMed 33766911

  • 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

  • Ching-Companioni RA, Diehl DL, Johal AS, Confer BD, Khara HS. 19 G aspiration needle versus 19 G core biopsy needle for endoscopic ultrasound-guided liver biopsy: a prospective randomized trial. Endoscopy. 2019 Nov;51(11):1059-1065. doi: 10.1055/a-0956-6922. Epub 2019 Jul 23.

    PubMed 31342474

  • Mok SRS, Diehl DL, Johal AS, Khara HS, Confer BD, Mudireddy PR, Kovach AH, Diehl MM, Kirchner HL, Chen ZE. Endoscopic ultrasound-guided biopsy in chronic liver disease: a randomized comparison of 19-G FNA and 22-G FNB needles. Endosc Int Open. 2019 Jan;7(1):E62-E71. doi: 10.1055/a-0655-7462. Epub 2019 Jan 4.

    PubMed 30648141

  • Facciorusso A, Crino SF, Ramai D, Fabbri C, Mangiavillano B, Lisotti A, Muscatiello N, Cotsoglou C, Fusaroli P. Diagnostic yield of endoscopic ultrasound-guided liver biopsy in comparison to percutaneous liver biopsy: a systematic review and meta-analysis. Expert Rev Gastroenterol Hepatol. 2022 Jan;16(1):51-57. doi: 10.1080/17474124.2022.2020645. Epub 2021 Dec 29.

    PubMed 34918578

  • Chandan S, Deliwala S, Khan SR, Mohan BP, Dhindsa BS, Bapaye J, Goyal H, Kassab LL, Kamal F, Sayles HR, Kochhar GS, Adler DG. EUS-guided versus percutaneous liver biopsy: A comprehensive review and meta-analysis of outcomes. Endosc Ultrasound. 2023 Mar-Apr;12(2):171-180. doi: 10.4103/EUS-D-21-00268.

    PubMed 36204798

  • Ali AH, Nallapeta NS, Yousaf MN, Petroski GF, Sharma N, Rao DS, Yin F, Davis RM, Bhat A, Swi AIA, Al-Juboori A, Ibdah JA, Hammoud GM. EUS-guided versus percutaneous liver biopsy: A prospective randomized clinical trial. Endosc Ultrasound. 2023 May-Jun;12(3):334-341. doi: 10.1097/eus.0000000000000010. Epub 2023 Jul 25.

    PubMed 37693114

  • 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

  • Neuberger J, Patel J, Caldwell H, Davies S, Hebditch V, Hollywood C, Hubscher S, Karkhanis S, Lester W, Roslund N, West R, Wyatt JI, Heydtmann M. Guidelines on the use of liver biopsy in clinical practice from the British Society of Gastroenterology, the Royal College of Radiologists and the Royal College of Pathology. Gut. 2020 Aug;69(8):1382-1403. doi: 10.1136/gutjnl-2020-321299. Epub 2020 May 28.

    PubMed 32467090

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Cirrhosis and Liver Disease Chronic, run by University Hospital Muenster at 1 site in Germany.

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 2 inclusion and 5 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 15 Jul 2026. 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 Germany. 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?

Biopsy specimen length (time frame: From enrollment within one week). The study lists 2 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 NCT07701031, which also lists 10 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 15 Jul 2026.

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