Laser microscope aims to spot dangerous pancreatic cysts

NCT ID NCT03492151

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Oct 13, 2026 · Last updated Oct 14, 2026 · Updated 1 time

Summary

Researchers are testing a technique called confocal laser endomicroscopy to help diagnose pancreatic cysts. The study enrolls adults with cysts at least 2 cm wide who are referred for an endoscopic ultrasound. During the procedure, doctors use a laser and a fluorescent dye to view the cyst lining at the cellular level, then collect fluid for lab tests. The goal is to see if this combined approach can better tell which cysts are likely to become cancerous and which are safe to leave alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
confocal laser endomicroscopy, a technique that uses a laser and fluorescent dye to view tissue at the cellular level during an endoscopy
What this could lead to
If it works, doctors could get a clearer picture of which pancreatic cysts are harmless and which need surgery, sparing some people unnecessary operations.
What could go wrong
The approach is still being tested and may not prove accurate enough to replace standard tests. The procedure also requires a dye that can cause allergic reactions in some people.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2018

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects for this study will be identified from patients referred for diagnostic EUS-FNA of PCLs for a non-study indication by a physician responsible for their care (i.e., gastroenterologists, oncologists, general internists, and surgeons) either at the primary study center.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient age 18 years or older * All patients referred for EUS-FNA of accessible PCL where surgery is contemplated * Minimum cyst size should be ≥ 2.0 cm as determined by prior cross-sectional imaging studies Exclusion Criteria: * Unable to obtain informed consent * Unable to tolerate the procedure * Women with known pregnancy at time of procedure * Patient age less than 18 years * Bleeding diathesis * Known allergy to fluorescein * Prior pancreatic cancer * Prior pancreatic surgery

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Conditions

The condition(s) this trial relates to.

Pancreatic Cyst pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Mayo Clinic Scottsdale Campus

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • NYU Langone Health

    RECRUITING

    Garden City, New York, 11530, United States

  • Parkview Hospital Randallia

    ACTIVE_NOT_RECRUITING

    Fort Wayne, Indiana, 46805, United States

  • Stanford Hospital

    RECRUITING

    Stanford, California, 94305, United States

  • The Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • The Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Yale School of Medicine

    RECRUITING

    New Haven, Connecticut, 06510, United States

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