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Evaluation of Pancreatic Cystic Lesions Via EUS-guided Fine Needle Aspiration With and Without Micro Forceps Biopsies
NCT04404101 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- PROCEDURE 1). EUS-FNA plus MFB
- PROCEDURE 2). EUS-FNA Alone
Study Locations (3)
California
- University of California Irvine — Irvine
Colorado
- University of Colorado - Anschutz Medical Campus — Aurora
Texas
- Baylor College of Medicine — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2021-05-11 |
| Est. Completion | 2025-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04404101
The ClinicalTrials.gov registry entry for NCT04404101 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,447 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pancreatic Cyst appearing as the primary indexed condition, and to 2 interventions — of which 1). EUS-FNA plus MFB is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04404101 reports 3 study locations spanning 3 distinct geographic areas — top geographies include California, Colorado, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04404101 about?
NCT04404101 is a clinical study titled "Evaluation of Pancreatic Cystic Lesions Via EUS-guided Fine Needle Aspiration With and Without Micro Forceps Biopsies". 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 (EU...
What is the current status of trial NCT04404101?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2021-05-11. Estimated completion is 2025-04.
What conditions does trial NCT04404101 study?
This clinical trial studies the following conditions: Pancreatic Cyst. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04404101?
The interventions under investigation include: 1). EUS-FNA plus MFB (PROCEDURE), 2). EUS-FNA Alone (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04404101?
This trial is sponsored by University of Colorado, Denver, which has 1,447 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04404101 being conducted?
This trial has 3 study locations across California, Colorado, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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