Assessing EUS and Percutaneous Untargeted Liver Biopsy Quality: A Sequential-Period Cluster-Randomized Study (EUS-PERC)

July 8, 2026 updated by: Prof. Dr. Michael Praktiknjo, University Hospital Muenster
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Münster, Germany, 48149
        • University Hospital Muenster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Percutaneous Liver Biopsy 18G Trucut
Diagnostic test: PC-LB 18G Trucut
Percutaneous Liver biopsy 18G Trucut
EUS-LB 19G FNA
Diagnostic test: EUS Liver biopsy 19G FNA
Liver biopsy performed with 19G FNA
EUS-LB 19G FNB
Diagnostic test: EUS LB 19G FNB
Liver biopsy performed with 19G FNB
EUS-LB 22G FNA
Diagnostic test: EUS LB 22G FNA
Liver biopsy performed with 22G FNA
EUS-LB 22G FNB
Diagnostic test: EUS LB 22G FNB
Liver biopsy performed with 22G FNB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biopsy specimen length and complete portal tracts
Time Frame: From enrollment within one week
From enrollment within one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall adequacy
Time Frame: 7 days (until pathologic examination finished)
CPT count ≥ 11 or Specimen length ≥ 15 mm
7 days (until pathologic examination finished)
Adverse events
Time Frame: 72 hours
Bleeding and pain
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

November 15, 2024

Study Registration Dates

First Submitted

July 8, 2026

First Submitted That Met QC Criteria

July 8, 2026

First Posted (Actual)

July 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSLB2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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