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Evaluating Pancreatic Cyst Sampling Methods

This study is comparing two ways to collect samples from pancreatic cysts (PCLs) to help doctors better understand them. One method is called EUS-FNA (Endoscopic Ultrasound-guided Fine Needle Aspiration), which uses a thin needle to take fluid. The other method adds MFB (Micro Forceps Biopsies) to EUS-FNA, allowing for a small tissue sample from the cyst wall. Researchers want to see if adding MFB improves how well doctors can diagnose these cysts and if it's safe. You might be able to join if you are an adult between 18 and 89 with a pancreatic cyst larger than 20mm that your doctor thinks needs further testing. The study is currently unclear on its recruitment status and plans to enroll 300 participants.

Study design
This is an interventional study comparing two different procedures for sampling pancreatic cysts. It aims to enroll 300 participants.
What's involved
You would undergo a procedure where your pancreatic cyst is sampled using either EUS-FNA alone or EUS-FNA with MFB.
Compensation
Not stated in the trial record.
Follow-up
Your safety and the clinical success of the procedure will be monitored for up to 4 weeks after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04404101

Evaluation of Pancreatic Cystic Lesions Via EUS-guided Fine Needle Aspiration With and Without Micro Forceps Biopsies

UNKNOWN
NAAges 18–89InterventionalDiagnostic
University of Colorado, Denver
~300 participants
Updated 2024-05-21 on ClinicalTrials.gov
What's tested:1). EUS-FNA plus MFB2). EUS-FNA Alone

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Technical Success of EUS-FNA plus MFB, with EUS-FNA alone for evaluation of PCLs.
Measured over Intraprocedural
+2 more outcomes measured

Conditions

Pancreatic Cyst

Explore related trials

Pancreatic Cyst

Where it's being run

3 sites across 3 states
California1
Colorado1
Texas1

Study leadership

  • Anna Duloy, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Anna Duloy, MD
[email protected]
+13037248892
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Technical Success of EUS-FNA plus MFB, with EUS-FNA alone for evaluation of PCLs.Intraprocedural

    (1) Technical success will be defined as the ability to puncture the cyst with the FNA needle under EUS guidance, advance the micro forceps into the cyst to perform cyst biopsies and obtain a visible tissue fragment.

  • Clinical Success of EUS-FNA plus MFB, with EUS-FNA alone for evaluation of PCLs.0-4 weeks

    (2) Clinical success will be defined as the ability to obtain a pathologic tissue diagnosis (diagnostic yield) of the PCL with MFB. Based on prior experience, expected diagnoses include pseudocyst, serous cystadenoma, mucinous cyst (mucinous cystic neoplasm, intra-ductal papillary mucinous neoplasm), adenocarcinoma, and neuroendocrine tumor, to name a few.

  • Safety of EUS-FNA plus MFB with that of EUS-FNA by recording adverse events per published ASGE (American Society for Gastrointestinal Endoscopy) criteria.0-4 Weeks

    Intraprocedural and post-procedural adverse events (e.g. bleeding, infection, perforation, pancreatitis, etc.)