Actively Recruiting

Phase Not Applicable
Age: 18Years - 89Years
All Genders
NCT04404101

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

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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