Patient Reported Outcomes In Liver Biopsy (EUS vs. Percutaneous) (PRO-LIVER)

April 1, 2026 updated by: Prof. Dr. Michael Praktiknjo, University Hospital Muenster

Patient-Reported Experience Measures Of EUS-Guided Versus Percutaneous Liver Biopsy: A Prospective Randomized Controlled Study

Patient Experience in Endohepatology Liver biopsy is a crucial procedure for the diagnosis and/or staging of liver diseases. Common indications for non-targeted biopsies include unexplained elevated liver function tests (LFTs), guiding medical therapy in autoimmune liver diseases or following liver transplantation (LT), and prognostic assessment in ambiguous clinical situations, occasionally within the scope of research.

Traditionally, there are three primary routes for obtaining liver biopsies: Percutaneous liver biopsy (PC-LB), transjugular (and thus endovascular) liver biopsy (TJ-LB), and surgical (mostly laparoscopic) approaches (LAP-LB). In recent years, endoscopic ultrasound-guided liver biopsy (EUS-LB) has gained significant importance as an alternative procedure. Technically, this approach usually involves puncturing the left liver lobe transgastrically using a 19G needle; however, the right liver lobe can also be targeted transduodenally. Regarding technical feasibility and cost-effectiveness, several studies report non-inferiority or even superiority compared to the standard percutaneous procedure.

Modern medicine increasingly recognizes that patient experience is a critical indicator of healthcare quality. While patient experience was mostly neglected in the past-aside from measuring the occurrence of pain-the modern definition encompasses the entire experience within the healthcare system, including social, somatic and organizational aspects. Consequently, this quality indicator is now assessed using validated questionnaires known as Patient-Reported Experience Measures (PREMs). The Newcastle-ENDOPREM was specifically developed and validated for the evaluation of endoscopic procedures.

Since EUS-LB and PC-LB perform similarly regarding technical aspects and safety, the question arises as to which method achieves higher patient satisfaction. This is particularly relevant as PC-LB is considered an unpleasant procedure that must frequently be repeated in patients with chronic liver diseases to guide medical therapy.

To the best of our knowledge, no direct head-to-head comparison between EUS-LB and PC-LB regarding patient experience has been conducted to date. Therefore, the aim of this study is to compare these two methods in terms of patient satisfaction with the procedure, using a modified version of the Newcastle-ENDOPREM.

  1. Current State of Science At the time of planning the implementation of endoscopic ultrasound-guided liver biopsy into the routine of Medical Clinic B, only one randomized controlled trial by Bang et al. exists comparing pain perception between the two procedures. This study indicates that percutaneous liver biopsy is more painful. The sample size calculation was performed according to the results of this study.
  2. Study Objectives The objective of the study is to measure the patient experience during liver biopsies and to identify the procedure that is better tolerated by patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48149
        • University hospital Muenster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing liver biopsy

Description

Inclusion Criteria:

  • Age above 18 years
  • Clinical indication for untargeted liver biopsy
  • Written informed consent

Exclusion Criteria:

  • Presence of ascites
  • Severe coagulopathy (INR > 2, platelet count < 50x10^3/µl)
  • Contraindication to undergo endoscopy or sedation
  • Anatomical alterations that impede liver biopsy (e.g. Chilaiditi syndrome)
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Percuteaneous Liver Biopsy
Procedure: Percutaneous Liver Biopsy
Liver Biopsy
EUS-Guided Liver Biopsy
Procedure: EUS Liver Biopsy
Liver Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported experience measure
Time Frame: Questionnaires are filled out immediately after the procedure once the patient is conscious enough to fill out the questionnaire.
Questionnaire for measuring patient experience. The questionnaire is based on the Newcastle ENDOPREM published by Neilson et al.. The modified PREM comprises six domains including completion of the PREM, referral, feelings before, during and after the procedure and overall experience. Most of the questions are likert-scaled (scaled from strongly aggree to strongly disaggree in five categories), few are categorical or visual analogue scaled. Every item has it's own scale regarding good or bad outcome. Items are analyzed independently.
Questionnaires are filled out immediately after the procedure once the patient is conscious enough to fill out the questionnaire.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Investigators

  • Principal Investigator: Michael Prof. Dr. Praktiknjo, MD, Universität Münster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 28, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-725-f-S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Restriction due to GDPR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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