Patient Reported Outcomes In Liver Biopsy (EUS vs. Percutaneous)
Key facts
- Who runs it
- University Hospital Muenster
- Where
- Germany1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 102 people enrolled
- Started
- 1 Sept 2023
- Ended
- 30 Sept 2024
- Type of study
- Observational, 2 groups
- Treatments tested
- EUS Liver Biopsy
- Percutaneous Liver Biopsy
- Record updated
- 7 April 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Age above 18 years
- Clinical indication for untargeted liver biopsy
- Written informed consent
Who cannot take part
- Anatomical alterations that impede liver biopsy (e.g. Chilaiditi syndrome)
- Severe coagulopathy (INR > 2, platelet count < 50x10\^3/µl)
- Presence of ascites
- Contraindication to undergo endoscopy or sedation
- Pregnancy
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Percuteaneous Liver Biopsy
Treatment: Percutaneous Liver Biopsy
- EUS-Guided Liver Biopsy
Treatment: EUS Liver Biopsy
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Patient-Reported Experience Measures Of EUS-Guided Versus Percutaneous Liver Biopsy: A Prospective Randomized Controlled Study
- Record updated
- 7 April 2026