Clinical trial NCT05295537: Percutaneous Versus Endoscopic Ultrasound-guided Liver Biopsy (PEREUS)
Official title: Prospective, Randomized, Comparative, Non-inferiority, Multicentre Trial of Quality of Samples Obtained by Percutaneous Liver Biopsy Versus Endoscopic Ultrasound-guided Liver Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Diseases
Keywords: Biopsy
Histology
Endoscopic ultrasound
Diagnosis
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel assignment.
Primary purpose: DIAGNOSTIC

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

Eligibility 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

Primary outcomes:
measure: Quality of tissue samples obtained by EUS-guided liver biopsy compared to percutaneous liver biopsy.
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Diagnostic accuracy of EUS-guided liver biopsy compared to percutaneous liver biopsy.
timeFrame: Up to 2 weeks
measure: Adverse events associated with EUS-guided liver biopsy compared to percutaneous liver biopsy.
timeFrame: At 1 hour, 4 hours, 24 hours, 7 days, and 30 days
measure: Patient satisfaction after EUS-guided liver biopsy compared to percutaneous liver biopsy.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
state: A Coruña
Study officials:
affiliation: Hospital Clínico Universitario de Santiago
name: J. Enrique Dominguez-Muñoz, MD, PhD
role: STUDY_DIRECTOR
References: