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NCT04404101 · ClinicalTrials.gov registry record · NA
Evaluation of Pancreatic Cystic Lesions Via EUS-guided Fine Needle Aspiration With and Without Micro Forceps Biopsies
A NA study of Pancreatic Cyst, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 3
- Study locations
NCT04404101: Recruiting NA study of Pancreatic Cyst, sponsored by University of Colorado, Denver.
NCT04404101 is a NA study of Pancreatic Cyst that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 300 participants, below the 534-participant average among 18 other Pancreatic Cyst trials with a reported enrollment target (44% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04404101, a NA study of Pancreatic Cyst, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 3
- Study locations
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 |
What NCT04404101 shows while recruiting
NCT04404101 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 534-participant average among 18 other Pancreatic Cyst trials with a reported enrollment target (44% lower).
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.
NCT04404101 reports a single indexed study location in California, Colorado, Texas.
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.
What interventions are being tested in trial NCT04404101?
The interventions under investigation include: 1). EUS-FNA plus MFB (PROCEDURE), 2). EUS-FNA Alone (PROCEDURE).
Who is sponsoring clinical trial NCT04404101?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04404101's enrollment target sits among peer trials
300 9th of 18 higher than 10 of 18 other Pancreatic Cyst trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cyst trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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