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NCT07506642: PRO-LIVER
Patient Reported Outcomes In Liver Biopsy (EUS vs. Percutaneous)
trial testing EUS Liver Biopsy in Chronic Liver Disease (CLD) in 102 participants. Completed in 30 September 2024.
30 September 2024
Quick facts
| Lead sponsor | University Hospital Muenster |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 102 |
| Start date | 1 September 2023 |
| Primary completion | 30 September 2024 |
| Estimated completion | 30 September 2024 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- EUS Liver Biopsy
- Percutaneous Liver Biopsy
Conditions studied
- Chronic Liver Disease (CLD) — all drugs for Chronic Liver Disease (CLD) →
- Liver Transplantation — all drugs for Liver Transplantation →
- Cirrhosis — all drugs for Cirrhosis →
Sponsor
University Hospital Muenster
Who can join
18 and older, any sex, with Chronic Liver Disease (CLD) or Liver Transplantation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07506642 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital Muenster
- Last refreshed: 7 April 2026
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