Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions

NCT ID: NCT03492151

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2026-12-31

Brief Summary

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The study schema is shown in Figure 4. (A) All patients referred to one of the participating academic centers for EUS evaluation of the PCL will be enrolled in the protocol if they satisfy inclusion criteria. Patient consent will be obtained during the clinic visit or prior to their EUS. EUS-guided nCLE imaging is first performed (B) followed by EUS-guided FNA and aspiration of cyst fluid. The cyst fluid is analyzed for CEA and cytology. As per institutional standard of care, the cyst fluid is also sent for molecular analysis. The results of the cyst fluid molecular analysis (B) will be utilized for the most likely diagnosis. Based on institutional multidisciplinary tumor board meetings, surgery is performed as indicated (C). Surgical histopathology serves as "gold standard" for diagnosis. It is anticipated that the majority of patients will undergo surgical resection after their EUS.

Detailed Description

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Conditions

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Pancreatic Cyst

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American College of Gastroenterology

OTHER

Sponsor Role collaborator

The National Pancreas Foundation

OTHER

Sponsor Role collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Somashekar Krishna

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Somashekar Krishna, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Mayo Clinic Scottsdale Campus

Scottsdale, Arizona, United States

Site Status RECRUITING

Stanford Hospital

Stanford, California, United States

Site Status RECRUITING

Yale School of Medicine

New Haven, Connecticut, United States

Site Status RECRUITING

Parkview Hospital Randallia

Fort Wayne, Indiana, United States

Site Status ACTIVE_NOT_RECRUITING

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

NYU Langone Health

Garden City, New York, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status RECRUITING

Baylor College of Medicine

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Megan Fry

Role: CONTACT

614-293-1056

Diana Burke

Role: CONTACT

Facility Contacts

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Veronica Oria

Role: primary

Samer El-Dika

Role: primary

Chloe Bennett

Role: primary

Kylie Ning

Role: primary

Roya Dastjerdi, MPH

Role: primary

Maria Marotta-Kollarus

Role: primary

Sharon Slomovich

Role: primary

Megan Fry

Role: primary

614-293-1056

Chandra Kovvali

Role: primary

713-798-2308

References

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Firkins SA, Chen W, Krishna SG. Morphologic and Microscopic Characterization of an Unusual Pancreatic Cystic Lesion. Gastroenterology. 2021 May;160(6):e14-e16. doi: 10.1053/j.gastro.2020.09.046. Epub 2020 Oct 8. No abstract available.

Reference Type DERIVED
PMID: 33039474 (View on PubMed)

Other Identifiers

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2017C0192

Identifier Type: -

Identifier Source: org_study_id

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