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Percutaneous Versus Endoscopic Ultrasound-guided Liver Biopsy (PEREUS)

Prospective, Randomized, Comparative, Non-inferiority, Multicentre Trial of Quality of Samples Obtained by Percutaneous Liver Biopsy Versus Endoscopic Ultrasound-guided Liver Biopsy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05295537
Acronym
PEREUS
Enrollment
92
Registered
2022-03-25
Start date
2022-01-19
Completion date
2022-12-01
Last updated
2023-03-01

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

Conditions

Liver Diseases

Keywords

Biopsy, Histology, Endoscopic ultrasound, Diagnosis

Brief summary

Although the use of liver biopsy (LB) has decreased with the emerging non-invasive markers and techniques to evaluate liver fibrosis, histopathologic examination of liver tissue is necessary to confirm the type of liver injury. The aim of our study is to compare two methods for obtaining histological material from the liver: the percutaneous liver biopsy (PLB) and the Endoscopic ultrasound (EUS) guided liver biopsy (EUS-LB)

Detailed description

LB remains the gold standard diagnostic test for most of the focal and parenchymal liver diseases. LB has an important diagnostic role in selected parenchymal liver diseases such as autoimmune hepatitis and infiltrative liver disorders, and in some cases, it helps clinicians to elucidate between overlapping diagnoses Traditionally, percutaneous (PLB) or transjugular approaches have been used to acquire liver samples. In recent tears EUS has emerged as an alternative and safe method to obtain liver samples, by puncturing the liver from the gastric or duodenal wall. In fact, EUS-guided LB has been shown equal or superior compared to PLB and transjugular approaches in retrospective series. EUS - LB has shown to produce excellent histological performance based on liver society guidelines requirements for parameters used in assessing histological yield which include the number of complete portal triads (CPT), sample size and total specimen length (TSL) with a low rate of adverse events EUS - LB has several advantages over the traditional liver biopsy methods: it provides simultaneous access to both liver lobes, enables real-time visualization avoiding the puncture of a large vessel and then reducing the rate of complications, it allows to perform a simultaneously endoscopic and endosonography evaluation of the pancreatobiliary system and it could decrease the level of the anxiety of patients (by the use of deep sedation) and then perhaps increasing the satisfaction with the procedure Despite the fact of the high diagnostic yield of EUS-LB in obtaining adequate samples from the liver and the low rate of adverse events reported with this method, there is an almost complete lack of randomized trials comparing EUS - LB with the traditional percutaneous route. The aim of our study is to compare the quality of samples obtained and the diagnostic efficacy of EUS - LB against PLB in all patients that have an indication for a liver biopsy

Interventions

PROCEDUREPERCUTANEOUS LIVER BIOPSY (PLB)

Percutaneous liver biopsy using a 16 gauge (G) Trucut needle.

PROCEDUREENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS-LB)

EUS-guided liver biopsy using a 19 gauge (G) Franseen core EUS needle

Sponsors

Hospital Clinico Universitario de Santiago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Randomized, parallel assignment.

Eligibility

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

Inclusion criteria

Patients for whom a liver biopsy have been indicated. Inclusion Criteria: * Age over 18 years, any gender * Understanding and informed consent signed * Fit for deep sedation

Exclusion criteria

* Age below 18 years * Not signed informed consent * Contraindication for a deep sedation * Pregnancy * Focal liver lesion that requires biopsy visualized by other imaging techniques * Coagulopathy (INR\>1.5 or platelets \< 50,000) * Inability to withdraw anticoagulant or antithrombotic agents

Design outcomes

Primary

MeasureTime frameDescription
Quality of tissue samples obtained by EUS-guided liver biopsy compared to percutaneous liver biopsy.Up to 2 weeksThe quality of samples is based in the combination of a specimen length \>20 mms and more than 10 complete portal triads (both conditions are required).

Secondary

MeasureTime frameDescription
Diagnostic accuracy of EUS-guided liver biopsy compared to percutaneous liver biopsy.Up to 2 weeksPercentage of samples allowing an adequate histological diagnosis.
Adverse events associated with EUS-guided liver biopsy compared to percutaneous liver biopsy.At 1 hour, 4 hours, 24 hours, 7 days, and 30 daysAdverse events evaluated according to the American Society of Gastrointestinal Endoscopy (ASGE) lexicon.
Patient satisfaction after EUS-guided liver biopsy compared to percutaneous liver biopsy.24 hoursSatisfaction survey that includes five points; four are questions scored from 1: bad to 5: excellent; and one is a dichotomic question (Yes/No). Survey will be performed 24 hours after the procedure by phone call.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026