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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percuteaneous Liver Biopsy |
| ||
| EUS-Guided Liver Biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS Liver Biopsy | Procedure | Liver Biopsy |
| |
| Percutaneous Liver Biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Questionnaires are filled out immediately after the procedure once the patient is conscious enough to fill out the questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing liver biopsy
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| Name | Affiliation | Role |
|---|---|---|
| Michael Prof. Dr. Praktiknjo, MD | Universität Münster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Muenster | Münster | North Rhine-Westphalia | 48149 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32419912 | Background | 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. | |
| 33766911 | Background |
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Restriction due to GDPR
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Procedure |
Liver Biopsy |
|
| 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. |
| 34829368 | 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. |
| 12145612 | 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. |
| 11172192 | 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. |
| 32467090 | 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. |