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

Description

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.

Conditions

Pancreatic Cyst

Study Overview

Study Details

Study overview

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.

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

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

Condition
Pancreatic Cyst
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Mayo Clinic Scottsdale Campus, Scottsdale, Arizona, United States, 85259

Stanford

Stanford Hospital, Stanford, California, United States, 94305

New Haven

Yale School of Medicine, New Haven, Connecticut, United States, 06510

Fort Wayne

Parkview Hospital Randallia, Fort Wayne, Indiana, United States, 46805

Baltimore

The Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Garden City

NYU Langone Health, Garden City, New York, United States, 11530

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Columbus

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

Houston

Baylor College of Medicine, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ohio State University Comprehensive Cancer Center,

Somashekar Krishna, MD, MPH, PRINCIPAL_INVESTIGATOR, The Ohio State University Wexner Medical Center

Study Record Dates

2025-12-31