Percutaneous Versus Endoscopic Ultrasound-guided Liver Biopsy (PEREUS)

NCT ID: NCT05295537

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-19
• Study Completion Date: 2022-12-01

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

Conditions

Liver Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PERCUTANEOUS LIVER BIOPSY (PLB)

Patients randomized to percutaneous liver biopsy.

Group Type: ACTIVE_COMPARATOR

PERCUTANEOUS LIVER BIOPSY (PLB)

Intervention Type: PROCEDURE

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

ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS - LB)

Patients randomized to EUS-guided liver biopsy

Group Type: EXPERIMENTAL

ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS-LB)

Intervention Type: PROCEDURE

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

Interventions

PERCUTANEOUS LIVER BIOPSY (PLB)

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

Intervention Type: PROCEDURE

ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS-LB)

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinico Universitario de Santiago

OTHER

Sponsor Role: lead

Responsible Party

J. Enrique Domínguez-Muñoz

Director of the Department of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

J. Enrique Dominguez-Muñoz, MD, PhD

Role: STUDY_DIRECTOR

Hospital Clínico Universitario de Santiago

Locations

Hospital Clinico Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Countries

Spain

Other Identifiers

USE-01-2021

Identifier Type: -

Identifier Source: org_study_id