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Assessing EUS and Percutaneous Untargeted Liver Biopsy Quality

NCT07701031 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 146

Last updated 2026-07-15

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

EUS Liver biopsy 19G FNA

Liver biopsy performed with 19G FNA

DIAGNOSTIC_TEST

EUS LB 19G FNB

Liver biopsy performed with 19G FNB

DIAGNOSTIC_TEST

EUS LB 22G FNB

Liver biopsy performed with 22G FNB

DIAGNOSTIC_TEST

EUS LB 22G FNA

Liver biopsy performed with 22G FNA

DIAGNOSTIC_TEST

PC-LB 18G Trucut

Percutaneous Liver biopsy 18G Trucut

Sponsors & Collaborators

  • University Hospital Muenster

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-11-01
Completion
2024-11-15

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07701031 on ClinicalTrials.gov