Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
CLIMB
1 other identifier
observational
500
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2018
CompletedFirst Posted
Study publicly available on registry
April 10, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
August 22, 2025
August 1, 2025
8.3 years
April 2, 2018
August 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Accuracy of PCL diagnosis
Diagnostic accuracy of confocal laser endomicroscopy and/or cyst fluid molecular markers and/or composite clinical and imaging features for the diagnosis of mucinous PCLs, PCLs with malignant potential, specific PCL types, and mucinous PCLs with advanced neoplasia.
48 months
Accuracy of risk-stratification of IPMNs
Diagnostic accuracy of confocal laser endomicroscopy and/or composite clinical and imaging features for the risk stratification of IPMNs
48 months
Secondary Outcomes (1)
Imaging quality
48 months
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Mayo Clinic Scottsdale Campus
Scottsdale, Arizona, 85259, United States
Stanford Hospital
Stanford, California, 94305, United States
Yale School of Medicine
New Haven, Connecticut, 06510, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805, United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
NYU Langone Health
Garden City, New York, 11530, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 33039474DERIVED
Biospecimen
Pancreas cyst fluid from EUS-nCLE
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Somashekar Krishna, MD, MPH
Ohio State University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 2, 2018
First Posted
April 10, 2018
Study Start
October 1, 2018
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
August 22, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share