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Assessing EUS and Percutaneous Untargeted Liver Biopsy Quality

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07701031
Acronym
EUS-PERC
Enrollment
146
Registered
2026-07-14
Start date
2023-01-01
Completion date
2024-11-15
Last updated
2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Liver Disease Chronic, Liver Transplant

Keywords

Endoscopic ultrasound, EUS, Liver biopsy

Brief 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 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.

Interventions

DIAGNOSTIC_TESTEUS Liver biopsy 19G FNA

Liver biopsy performed with 19G FNA

DIAGNOSTIC_TESTEUS LB 19G FNB

Liver biopsy performed with 19G FNB

DIAGNOSTIC_TESTEUS LB 22G FNB

Liver biopsy performed with 22G FNB

DIAGNOSTIC_TESTEUS LB 22G FNA

Liver biopsy performed with 22G FNA

DIAGNOSTIC_TESTPC-LB 18G Trucut

Percutaneous Liver biopsy 18G Trucut

Sponsors

University Hospital Muenster
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Biopsy specimen lengthFrom enrollment within one week
Number of complete portal tractsFrom enrollment within one week

Secondary

MeasureTime frameDescription
Overall adequacy7 days (until pathologic examination finished)Specimen length ≥ 15 mm
Adverse events72 hoursBleeding and pain
Number of complete portal tracts ≥ 117 days (until pathologic examination finished)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026