NCT05295537

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

January 19, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

January 16, 2022

Last Update Submit

February 28, 2023

Conditions

Liver Diseases

Keywords

BiopsyHistologyEndoscopic ultrasoundDiagnosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Diagnostic accuracy of EUS-guided liver biopsy compared to percutaneous liver biopsy.

    Up to 2 weeks

  • Adverse events associated with EUS-guided liver biopsy compared to percutaneous liver biopsy.

    At 1 hour, 4 hours, 24 hours, 7 days, and 30 days

  • Patient satisfaction after EUS-guided liver biopsy compared to percutaneous liver biopsy.

    24 hours

Study Arms (2)

PERCUTANEOUS LIVER BIOPSY (PLB)

ACTIVE COMPARATOR

Patients randomized to percutaneous liver biopsy.

Procedure: PERCUTANEOUS LIVER BIOPSY (PLB)

ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS - LB)

EXPERIMENTAL

Patients randomized to EUS-guided liver biopsy

Procedure: ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS-LB)

Interventions

PERCUTANEOUS LIVER BIOPSY (PLB)PROCEDURE

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

PERCUTANEOUS LIVER BIOPSY (PLB)
ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS-LB)PROCEDURE

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

ENDOSCOPIC ULTRASOUND GUIDED LIVER BIOPSY (EUS - LB)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years, any gender
  • Understanding and informed consent signed
  • Fit for deep sedation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

MeSH Terms

Conditions

Liver DiseasesDisease

Condition Hierarchy (Ancestors)

Digestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • J. Enrique Dominguez-Muñoz, MD, PhD

    Hospital Clínico Universitario de Santiago

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Randomized, parallel assignment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Department of Gastroenterology

Study Record Dates

First Submitted

January 16, 2022

First Posted

March 25, 2022

Study Start

January 19, 2022

Primary Completion

September 1, 2022

Study Completion

December 1, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)