Comparing two methods for liver biopsy in patients with liver disease
Bloody or Well Done. How Would You Like Your Liver Biopsy, Sir? Post Liver bIopsy abdoMinal PaIn as Predictive Factor for Liver bleeDing (LIMPID)
This study is testing whether a new way to take liver biopsies using endoscopic ultrasound can cause less bleeding and pain compared to the traditional method for people with liver disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Carol Davila University of Medicine and Pharmacy Academic / other |
| Locations | 1 site (Bucharest) |
| Trial ID | NCT06231082 on ClinicalTrials.gov |
What this trial studies
This trial compares the efficacy and safety of percutaneous liver biopsy with endoscopic ultrasound-guided fine needle biopsy (EUS FNB) in patients diagnosed with parenchymal liver disease. The study aims to determine if EUS FNB can reduce the incidence of liver bleeding and abdominal pain compared to traditional percutaneous methods. Participants will be randomly assigned to one of the two biopsy techniques, and outcomes will be assessed based on diagnostic accuracy and safety profiles. The trial is designed to ensure optimal conditions for EUS FNB to achieve non-inferior results to percutaneous biopsies.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with diffuse parenchymal liver disease requiring a biopsy for diagnostic or staging purposes.
Not a fit: Patients with coagulation disorders that cannot be corrected or those on anticoagulant medications that cannot be temporarily stopped will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective liver biopsy techniques for patients with liver disease.
How similar studies have performed: Previous studies have indicated that EUS FNB is non-inferior to percutaneous liver biopsy, suggesting a promising approach for this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diffuse parenchymal liver disease with indication for liver biopsy for diagnostic and/or staging purposes, * Eligibility for deep sedation with propofol * Age above 18 years old * Informed consent Exclusion Criteria: * Coagulation disorders which cannot be corrected * Anticoagulant and/or antiagregant medication which cannot be stopped temporarily. * Contraindications for liver biopsy, to local lidocaine anesthesia and to deep propofol sedation * Absence of written informed consent
Where this trial is running
Bucharest
- "Prof. Dr. Agrippa Ionescu" Clinical and Emerency Hospital — Bucharest, Romania (Recruiting)
Study contacts
- Study coordinator: Mihai Ciocirlan
- Email: ciocirlanm@yahoo.com
- Phone: 0040722322625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.