Percutaneous Versus Endoscopic Ultrasound-guided Liver Biopsy (PEREUS) (PEREUS)

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

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)

Study Overview

• Status: Completed
• Conditions: Liver Diseases
• Intervention / Treatment: Procedure: PERCUTANEOUS LIVER BIOPSY (PLB); Procedure: ENDOSCOPIC ULTRASOUND 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

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Hospital Clínico Universitario de Santiago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PERCUTANEOUS LIVER BIOPSY (PLB); Patients randomized to percutaneous liver biopsy.	Procedure: PERCUTANEOUS LIVER BIOPSY (PLB); Percutaneous liver biopsy using a 16 gauge (G) Trucut needle.
Experimental: ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS - LB); Patients randomized to EUS-guided liver biopsy	Procedure: ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS-LB); EUS-guided liver biopsy using a 19 gauge (G) Franseen core EUS needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of tissue samples obtained by EUS-guided liver biopsy compared to percutaneous liver biopsy.	The 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).	Up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of EUS-guided liver biopsy compared to percutaneous liver biopsy.	Percentage of samples allowing an adequate histological diagnosis.	Up to 2 weeks
Adverse events associated with EUS-guided liver biopsy compared to percutaneous liver biopsy.	Adverse events evaluated according to the American Society of Gastrointestinal Endoscopy (ASGE) lexicon.	At 1 hour, 4 hours, 24 hours, 7 days, and 30 days
Patient satisfaction after EUS-guided liver biopsy compared to percutaneous liver biopsy.	Satisfaction 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.	24 hours

Collaborators and Investigators

• Sponsor: Hospital Clinico Universitario de Santiago

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: January 16, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Biopsy; Diagnosis; Endoscopic ultrasound; Histology
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hematinics; Liver Extracts
• Other Study ID Numbers: USE-01-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No