Actively Recruiting
Evaluation of Pancreatic Cystic Lesions Via EUS-guided Fine Needle Aspiration With and Without Micro Forceps Biopsies
Led by University of Colorado, Denver · Updated on 2024-05-21
300
Participants Needed
3
Research Sites
203 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
U
US Endoscopy
Collaborating Sponsor
AI-Summary
What this Trial Is About
Pancreatic cystic lesions (PCLs) are a common incidental finding in cross sectional imaging (up to 27% on CT scan and 41% on MRI) and pose a management challenge to physicians. According to society guidelines, PCLs with specific features should prompt additional workup with endoscopic ultrasound (EUS) for cyst characterization as well as cyst sampling. This can help determine if the cyst is mucinous or non-mucinous which has implications for its malignant potential. Cyst fluid has traditionally been sampled using EUS with fine needle aspiration (EUS-FNA) and sent for fluid analysis and cytology. More recently, the adjunctive use of the through-the-scope micro forceps (Moray micro forceps, US Endoscopy, Mentor, OH) biopsy (EUS-MFB) has shown promise for diagnosis of PCLs. This technology utilizes a micro forceps through a 19-gauge needle to biopsy the cyst wall for histology, in addition to collecting cyst fluid for CEA level and cytology. More recently, the adjunctive use of the Moray® through the needle micro forceps biopsy (EUS-MFB) has shown promise for diagnosis of PCLs. This technology utilizes a micro forceps through a 19-gauge needle to biopsy the cyst wall for histology, in addition to collecting cyst fluid for CEA level and cytology. Only a few small retrospective reports have been published regarding the use of MFB. The results of this study will hopefully help increase diagnostic yield by obtaining a histopathologic diagnosis of these PCLs, and potentially affect practice patterns of gastroenterologists and the endoscopic community, specifically those physicians who perform EUS in these patients. Furthermore, the results will help determine whether there is reason to continue this line of research to obtain a definite histologic tissue diagnosis of PCLs.
CONDITIONS
Official Title
Evaluation of Pancreatic Cystic Lesions Via EUS-guided Fine Needle Aspiration With and Without Micro Forceps Biopsies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients older than 18 years
- Pancreatic cysts larger than 20 mm suitable for fine needle aspiration based on clinical and imaging evaluation
You will not qualify if you...
- Younger than 18 years old
- Unable to provide informed consent
- Low platelet count (less than 50,000) or blood clotting problems (INR over 1.8)
- Pregnancy
- Surgical changes preventing cyst access for aspiration
- Endoscopic ultrasound findings that make cyst aspiration unsafe (such as nearby blood vessels)
- Cysts that appear too small or not visible on ultrasound or suggest serous cystadenoma making aspiration unnecessary
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of California Irvine
Irvine, California, United States, 92697
Actively Recruiting
2
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Baylor College of Medicine
Houston, Texas, United States, 77030
Enrolling by Invitation
Research Team
A
Anna Duloy, MD
CONTACT
S
Sandra Boimbo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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