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

NCT07506642 | Completed

• 1 other identifier: 2023-725-f-S
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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 accessed 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. 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. 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.

Conditions

Chronic Liver Disease (CLD); Liver Transplantation; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Patient reported experience measure

  Questionnaire for measuring patient experience. The questionnaire is based on the Newcastle ENDOPREM published by Neilson et al.. The modified PREM comprises 6 domains including completion of the PREM, referral, feelings before, during and after the procedure and overall experience. Most of the questions are likert-scaled, few are categorical or visual analogue scaled. Items are analyzed independently.

  Questionnaires are fullfilled immediately after the procedure once the patient is conscious enough to fill out the questionnaire.

Study Arms (2)

Percuteaneous Liver Biopsy

Procedure: Percutaneous Liver Biopsy

EUS-Guided Liver Biopsy

Procedure: EUS Liver Biopsy

Interventions

EUS Liver Biopsy PROCEDURE

Liver Biopsy

EUS-Guided Liver Biopsy

Percutaneous Liver Biopsy PROCEDURE

Liver Biopsy

Percuteaneous Liver Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing liver biopsy

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Related Publications (5)

• Bang JY, Ward TJ, Guirguis S, Krall K, Contreras F, Jhala N, Navaneethan U, Hawes RH, Varadarajulu S. Radiology-guided percutaneous approach is superior to EUS for performing liver biopsies. Gut. 2021 Dec;70(12):2224-2226. doi: 10.1136/gutjnl-2021-324495. Epub 2021 Mar 25. No abstract available.

  PMID: 33766911 BACKGROUND

• Pavic T, Mikolasevic I, Kralj D, Blazevic N, Skrtic A, Budimir I, Lerotic I, Hrabar D. Role of Endoscopic Ultrasound in Liver Disease: Where Do We Stand? Diagnostics (Basel). 2021 Oct 31;11(11):2021. doi: 10.3390/diagnostics11112021.

  PMID: 34829368 BACKGROUND

• Wiersema MJ, Levy MJ, Harewood GC, Vazquez-Sequeiros E, Jondal ML, Wiersema LM. Initial experience with EUS-guided trucut needle biopsies of perigastric organs. Gastrointest Endosc. 2002 Aug;56(2):275-8. doi: 10.1016/s0016-5107(02)70193-4.

  PMID: 12145612 BACKGROUND

• Bravo AA, Sheth SG, Chopra S. Liver biopsy. N Engl J Med. 2001 Feb 15;344(7):495-500. doi: 10.1056/NEJM200102153440706. No abstract available.

  PMID: 11172192 BACKGROUND

• Neuberger J, Patel J, Caldwell H, Davies S, Hebditch V, Hollywood C, Hubscher S, Karkhanis S, Lester W, Roslund N, West R, Wyatt JI, Heydtmann M. Guidelines on the use of liver biopsy in clinical practice from the British Society of Gastroenterology, the Royal College of Radiologists and the Royal College of Pathology. Gut. 2020 Aug;69(8):1382-1403. doi: 10.1136/gutjnl-2020-321299. Epub 2020 May 28.

  PMID: 32467090 BACKGROUND

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Praktiknjo, MD

  Universität Münster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of hepatology

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 2, 2026
• Study Start: September 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)