Evaluating different techniques for endoscopic ultrasound fine needle biopsy
Diagnostic Efficacy Of 3 Endoscopic Ultrasound-Guided Fine Needle Biopsy Techniques In Solid Masses: A Randomized Clinical Trial
This study is testing three different ways to perform a needle biopsy using endoscopic ultrasound to see which method gives the best results for diagnosing abdominal lesions in patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario Insular Gran Canaria Academic / other |
| Locations | 2 sites (Las Palmas De Gran Canaria, Las Palmas and 1 other locations) |
| Trial ID | NCT05825729 on ClinicalTrials.gov |
What this trial studies
This study evaluates the diagnostic efficacy of three different endoscopic ultrasound fine needle biopsy (EUS-FNB) techniques: dry suction, slow-pull, and wet suction. It aims to determine which technique provides the best results in obtaining accurate cytological and histological samples from intra-abdominal lesions. The study will involve patients who have been referred for EUS-FNB after imaging tests and will assess factors such as needle size and the number of passes made on the lesion. The findings could help refine biopsy techniques and improve diagnostic accuracy for gastrointestinal cancers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with lesions greater than 1 cm that require biopsy following imaging tests.
Not a fit: Patients with coagulopathy, severe heart or respiratory failure, or those on anticoagulants that cannot be suspended may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing intra-abdominal lesions, leading to better patient outcomes.
How similar studies have performed: While EUS-FNB techniques have been widely used, this specific comparison of techniques is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Age ≥ 18 years * Patients referred for EUS-FNB after imaging tests (CT, MRI, or abdominal ultrasound) of pancreatic, non-pancreatic intraabdominal, mediastinal, or pelvic lesions greater than 1 cm. * Signed informed consent. Exclusion criteria * Coagulopathy (INR\> 1.5) or thrombocytopenia (\<50,000) * Severe heart or respiratory failure that contraindicates sedation. * Use of anticoagulants and antiplatelet agents that cannot be suspended. * Use of a needle of a different gauge to 22G * Refusal to sign informed consent.
Where this trial is running
Las Palmas De Gran Canaria, Las Palmas and 1 other locations
- Hospital Universitario Doctor Negrin de Gran Canaria — Las Palmas De Gran Canaria, Las Palmas, Spain (Recruiting)
- Complejo Hospitalario Universitario Materno Infantil — Las Palmas De Gran Canaria, Las Palmas, Spain (Recruiting)
Study contacts
- Principal investigator: Guillermo Perez-Aguado, MD — Chuimi
- Study coordinator: Guillermo Perez-Aguado, MD
- Email: guiperez92@gmail.com
- Phone: +34647369686
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.