Comparing two needle sizes for liver biopsies using endoscopic ultrasound
Sample Adequacy and Diagnostic Accuracy of a 22 Gauge FNB Needle Vs a 19G FNB Needle for EUS-guided Liver Biopsy: a Prospective Trial
PHASE4 · Duzce University · NCT06643520
This study tests whether using a thicker or thinner needle for liver biopsies helps doctors get better samples and make more accurate diagnoses for patients with unexplained liver issues.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Duzce University (other) |
| Locations | 1 site (Duzce) |
| Trial ID | NCT06643520 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of 19-gauge and 22-gauge needles for endoscopic ultrasound-guided liver biopsies. It aims to determine which needle size provides better sample adequacy and diagnostic accuracy while assessing safety in patients with unexplained liver enzyme elevation. The same endoscopist will perform the biopsies on the same liver lobe during the same session to ensure consistency in results. The findings could clarify ongoing debates regarding optimal needle size for this procedure.
Who should consider this trial
Good fit: Ideal candidates include patients with unexplained elevation of liver enzymes and suspected hepatic parenchymal disease.
Not a fit: Patients with malignancy, decompensated cirrhosis, ascites, coagulopathy, or those on anticoagulants will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and safety in liver biopsies, benefiting patients with liver disease.
How similar studies have performed: Previous studies have shown mixed results regarding needle size effectiveness, making this approach both relevant and necessary for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients with unexplained elevation of liver enzymes and suspected hepatic paranchymal disease Exclusion Criteria: * Patients who had malignancy * Patients who have decompensated cirrhosis * Presence of ascites * Patients with coagulopathy (platelets \< 50.000 μ/ mL and INR \> 1.5) * The use of anticoagulant agents * Pregnancy * Unable to provide written informed consent
Where this trial is running
Duzce
- Duzce University — Duzce, Turkey (RECRUITING)
Study contacts
- Study coordinator: Salih Tokmak, Assoc.Prof of GI
- Email: salihtokmak@duzce.edu.tr
- Phone: +905052532698
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.
Conditions: Endoscopic Ultrasonography, Liver Biopsy