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OpenTrials
Completed

NCT Number: NCT07701031

Assessing EUS and Percutaneous Untargeted Liver Biopsy Quality

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Muenster

Münster, 48149, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EUS Liver biopsy 19G FNA

Diagnostic Test

Liver biopsy performed with 19G FNA

EUS LB 19G FNB

Diagnostic Test

Liver biopsy performed with 19G FNB

EUS LB 22G FNB

Diagnostic Test

Liver biopsy performed with 22G FNB

EUS LB 22G FNA

Diagnostic Test

Liver biopsy performed with 22G FNA

PC-LB 18G Trucut

Diagnostic Test

Percutaneous Liver biopsy 18G Trucut

Primary outcomes

  1. Biopsy specimen length

    Time frame: From enrollment within one week

  2. Number of complete portal tracts

    Time frame: From enrollment within one week

Secondary outcomes

  1. Overall adequacy

    Time frame: 7 days (until pathologic examination finished)

    Specimen length ≥ 15 mm

  2. Adverse events

    Time frame: 72 hours

    Bleeding and pain

  3. Number of complete portal tracts ≥ 11

    Time frame: 7 days (until pathologic examination finished)

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Official study title

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

Acronym: EUS-PERC

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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