EUS-guided Versus Percutaneous Ultrasound-guided Biopsy for Parenchymal Liver Disease (NCT06047327) | Clinical Trial Compass
CompletedNot Applicable
EUS-guided Versus Percutaneous Ultrasound-guided Biopsy for Parenchymal Liver Disease
India90 participantsStarted 2023-11-01
Plain-language summary
Liver biopsy may be indicated in various clinical scenarios to help diagnose and manage liver diseases. Endoscopic ultrasound (EUS) liver biopsy and percutaneous USG guided liver biopsy are two methods used to obtain liver tissue samples. EUS involves using an endoscope with an ultrasound probe to guide a needle through the stomach wall and into the liver, while percutaneous ultrasound guided biopsy involves inserting a needle directly through the skin and into the liver using ultrasound guidance.
A specimen measuring 15 mm or more and containing 6 to 8 CPTs is generally considered adequate for the histologic diagnosis of diffuse liver disease. However, stricter requirements of specimen length of 20 mm or longer with 11 or more CPTs for reliable grading and staging of chronic viral hepatitis have been recommended. With this study we aim to study in a head-to-head comparison between EUS-guided and percutaneous (PC) liver biopsies, with regards to tissue acquisition adequacy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients \> 18 years of age.
. Eligibility for deep sedation with propofol.
. Undergoing liver biopsy for diagnosis/evaluation/staging.
Exclusion criteria
. Coagulopathy, defined by platelet count \< 70,000/mL and/or INR \> 1.7.
. Inability to discontinue anticoagulation or antiplatelet agents for 5 days prior to the procedure.
. Presence of unrelieved biliary obstruction.
. Presence of ascites.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Specimen adequacy defined by total specimen length (TSL) ≥ 15 mm and ≥ 8 complete portal triads (CPTs)
Timeframe: Day 0
Trial details
NCT IDNCT06047327
SponsorInstitute of Liver and Biliary Sciences, India