Evaluating pancreatic cysts using advanced biopsy techniques
Evaluation of Pancreatic Cystic Lesions Via EUS-Guided Fine Needle Aspiration With and Without Micro Forceps Biopsies: A Multi-Center Prospective Randomized Study
This study is testing if adding a special biopsy tool to a common procedure can help doctors better diagnose pancreatic cysts in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 3 sites (Irvine, California and 2 other locations) |
| Trial ID | NCT04404101 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the diagnosis of pancreatic cystic lesions (PCLs) by comparing two methods: endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) with and without the addition of micro forceps biopsies (EUS-MFB). PCLs are often found incidentally during imaging and can vary in their potential for malignancy, making accurate diagnosis crucial. The study will involve adult patients with cysts larger than 20 mm, assessing the effectiveness of EUS-MFB in providing histological information alongside traditional fluid analysis. The goal is to enhance diagnostic accuracy and better inform management decisions for patients with PCLs.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with pancreatic cysts larger than 20 mm that are appropriate for fine needle aspiration.
Not a fit: Patients who may not benefit from this study include those under 18 years old, those with certain blood disorders, or those whose cysts are deemed unsafe for aspiration.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of pancreatic cysts, potentially reducing unnecessary surgeries and improving patient outcomes.
How similar studies have performed: While few small retrospective reports have explored the use of micro forceps biopsies for pancreatic cysts, this approach is relatively novel and has not been extensively tested in larger studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients \>18 years old * Cysts \> 20 mm in size deemed appropriate for FNA by the endoscopist, based on clinical presentation, radiologic imaging features, associated solid mass or nodules, and patient anxiety about the diagnosis Exclusion Criteria: * Age \<18 years * Inability to provide informed consent * Thrombocytopenia (Platelets \< 50,000) or coagulopathy (INR \> 1.8) * Pregnancy * Post-surgical anatomy where the cyst is not accessible for FNA * EUS findings suggesting that cyst FNA would be unsafe (e.g. intervening blood vessels) * EUS appearance suggesting FNA is not indicated (e.g. cyst smaller than prior radiologic imaging, cyst not seen, EUS suggestive of serous cystadenoma)
Where this trial is running
Irvine, California and 2 other locations
- University of California Irvine — Irvine, California, United States (Recruiting)
- University of Colorado - Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Enrolling_by_invitation)
Study contacts
- Principal investigator: Anna Duloy, MD — University of Colorado, Denver
- Study coordinator: Anna Duloy, MD
- Email: anna.duloy@cuanschutz.edu
- Phone: +13037248892
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.