Using advanced ultrasound-guided needles to sample tissue from biliary strictures
Endoscopic Ultrasound-guided Fine-needle Biopsy for Tissue Sampling of Biliary Strictures: a Multicenter Prospective Study
This study is testing new ultrasound-guided needles to see if they can help doctors get better tissue samples from biliary strictures in patients who may have cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ospedali Riuniti di Foggia Academic / other |
| Locations | 2 sites (Foggia, FG and 1 other locations) |
| Trial ID | NCT06614452 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of new endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) techniques for obtaining tissue samples from biliary strictures. It focuses on the use of advanced 'end-cutting' needles, which have shown high diagnostic accuracy in other abdominal lesions. The study aims to improve diagnostic outcomes for patients with biliary strictures, particularly those without visible masses on imaging. By comparing the performance of these new needles against traditional methods, the research seeks to establish a more reliable approach for diagnosing malignancies in biliary strictures.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with suspicious biliary strictures but no abdominal mass visible on imaging.
Not a fit: Patients with known pancreatic or abdominal masses affecting the bile duct, or those with bleeding disorders that cannot be corrected, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of biliary strictures, allowing for timely and appropriate treatment for patients.
How similar studies have performed: Previous studies have shown promising results with similar advanced EUS techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Suspicious biliary stricture in absence of an abdominal mass at cross-sectional imaging * Distal and peri-hilar biliary strictures * Informed consent provided by the patient or the closest relative Exclusion Criteria: * Presence of a pancreatic or abdominal mass structuring the common bile duct * EUS not feasible * Known bleeding disorder that cannot be sufficiently corrected with fresh frozen plasma (FFP) * Use of anticoagulants that cannot be discontinued * INR \>1.5 or platelet count \<50.000 * Pregnancy
Where this trial is running
Foggia, FG and 1 other locations
- Ospedali Riuniti di Foggia — Foggia, Fg, Italy (Recruiting)
- Università di Verona — Verona, Vr, Italy (Recruiting)
Study contacts
- Study coordinator: Antonio Facciorusso, MD PhD
- Email: antonio.facciorusso@virgilio.it
- Phone: +390881732134
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.