University Hospital Muenster
Münster, 48149, Germany
NCT Number: NCT07701031
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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Notify Me18 year and older
All sexes
Observational
Münster, 48149, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Liver biopsy performed with 19G FNA
Liver biopsy performed with 19G FNB
Liver biopsy performed with 22G FNB
Liver biopsy performed with 22G FNA
Percutaneous Liver biopsy 18G Trucut
Time frame: From enrollment within one week
Time frame: From enrollment within one week
Time frame: 7 days (until pathologic examination finished)
Specimen length ≥ 15 mm
Time frame: 72 hours
Bleeding and pain
Time frame: 7 days (until pathologic examination finished)
University Hospital Muenster
Other
Assessing EUS and Percutaneous Untargeted Liver Biopsy Quality: A Sequential-Period Cluster-Randomized Study
Acronym: EUS-PERC
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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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