Chronic Liver Disease (CLD)PRO-LIVERNCT07506642
Patient Reported Outcomes In Liver Biopsy (EUS vs. Percutaneous)
An observational study of Chronic Liver Disease (CLD) and Liver Transplantation, run by University Hospital Muenster at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease (CLD), Liver Transplantation, Cirrhosis
- What is being tested?
- EUS Liver Biopsy and Percutaneous Liver Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 102 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2023to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing liver biopsy
Who may be able to join
- Age above 18 years
- Clinical indication for untargeted liver biopsy
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Muenster
Münster, North Rhine-Westphalia, 48149
About this study
Official title: 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.
Read more
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.
- 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.
- 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.
- Being tested
- EUS Liver Biopsy, Percutaneous Liver Biopsy
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS Liver BiopsyProcedure or surgery
Liver Biopsy
Percutaneous Liver BiopsyProcedure or surgery
Liver Biopsy
| Study group | Role | What they receive |
|---|---|---|
| Percuteaneous Liver Biopsy | Not described Receives: Procedure: Percutaneous Liver Biopsy | |
| EUS-Guided Liver Biopsy | Not described Receives: Procedure: EUS Liver Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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.
Measured: Questionnaires are filled out immediately after the procedure once the patient is conscious enough to fill out the questionnaire.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Sep 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver Disease (CLD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Michael Praktiknjo, University Hospital Muenster
- Investigators
- Michael Prof. Dr. Praktiknjo, MD, Principal investigator, Universität Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506642
- Sponsor's protocol ID
- 2023-725-f-S
- Acronym
- PRO-LIVER
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Restriction due to GDPR
Publications
Neilson LJ, Patterson J, von Wagner C, Hewitson P, McGregor LM, Sharp L, Rees CJ. Patient experience of gastrointestinal endoscopy: informing the development of the Newcastle ENDOPREM. Frontline Gastroenterol. 2020 Jan 13;11(3):209-217. doi: 10.1136/flgastro-2019-101321. eCollection 2020.
PubMed 32419912Bang 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.
PubMed 33766911Pavic 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.
PubMed 34829368Wiersema 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.
PubMed 12145612Bravo 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.
PubMed 11172192Neuberger 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.
PubMed 32467090
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Experience Measures Of EUS-Guided Versus Percutaneous Liver Biopsy: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07506642
- Acronym / sponsor ID
- PRO-LIVER / 2023-725-f-S
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percuteaneous Liver Biopsy | – | Procedure: Percutaneous Liver Biopsy |
| EUS-Guided Liver Biopsy | – | Procedure: EUS Liver Biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing liver biopsy
Key inclusion criteria (3 listed)
- Age above 18 years
- Clinical indication for untargeted liver biopsy
- Written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS Liver BiopsyLiver Biopsy | Procedure or surgery | EUS-Guided Liver Biopsy |
| Percutaneous Liver BiopsyLiver Biopsy | Procedure or surgery | Percuteaneous Liver Biopsy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 32419912Neilson LJ, Patterson J, von Wagner C, Hewitson P, McGregor LM, Sharp L, Rees CJ. Patient experience of gastrointestinal endoscopy: informing the development of the Newcastle ENDOPREM. Frontline Gastroenterol. 2020 Jan 13;11(3):209-217. doi: 10.1136/flgastro-2019-101321. eCollection 2020.
- Background: PubMed 33766911Bang 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.
- Background: PubMed 34829368Pavic 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.
- Background: PubMed 12145612Wiersema 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.
- Background: PubMed 11172192Bravo 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.
- Background: PubMed 32467090Neuberger 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.
- Individual participant dataSharing planned: No. Restriction due to GDPR
Related trials for Chronic Liver Disease (CLD)
RecruitingPhase 4
Phase 4, Double-blind Study Evaluating the Response on Computed Tomography (CT) Lung Density Decline Rates of Respreeza / Zemaira Weekly for 3 Years in Adults With alpha1 Antitrypsin Deficiency (AATD)
Alpha1 Antitrypsin Deficiency, Alpha1-Proteinase Inhibitor Deficiency
Recruiting
EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG
Portal Hypertension, Chronic Liver Disease (CLD)
RecruitingObservational study
To Study the Clinical Course and Outcomes of Non-electively Hospitalised Patients of Chronic Liver Disease (CLD) With Hepatic or Extra-hepatic Predominant Organ Failure(s) at 6 Months.
Chronic Liver Disease
RecruitingPhase 4
Vitamin D2 vs Vitamin D2 Plus Calcitriol in Cholestatic Children With Vitamin D Deficiency
Cholestatic Liver Disease, Chronic Liver Disease (CLD)
Active, not recruitingObservational study
Identification of Patients With Advanced Chronic Diseases in Need of Palliative Care
Cancer, Chronic Liver Disease (CLD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Prof. Dr. Praktiknjo, MD principal investigator
Universität Münster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease (CLD) and Liver Transplantation, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07506642, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.