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RecruitingNCT03492151CLIMBUpdated Oct 13, 2026

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

An observational study in Pancreatic Cyst, sponsored by Ohio State University Comprehensive Cancer Center. Recruiting at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Ohio State University Comprehensive Cancer Center · Observational

From the registry’s dates

  • Started Oct 2018; still recruiting 8 years 1 month later.
Updated Oct 13, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pancreatic Cyst

Keywords

  • Confocal laser endomicroscopy
  • pancreatic cancer
  • IPMN
03

In context

Pancreatic Cyst

97 studies on the registry are indexed under Pancreatic Cyst; 37 are open to participants now.

This study's planned enrollment of 500 is above the median of 300 across 55 observational studies indexed under Pancreatic Cyst.

Browse Pancreatic Cyst studies →

Lead sponsor

Ohio State University Comprehensive Cancer Center is the lead sponsor of 377 studies on the registry; 84 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Unable to obtain
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
None retained
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 48 months

  2. 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

    Time frame: 48 months

Secondary outcomes

  1. Imaging quality

    Optimal quality of imaging obtained during in vivo confocal laser endomicroscopy of pancreatic cystic lesions

    Time frame: 48 months

07

Study locations

9 of 10 sites recruiting
08

References and documents

Publications

  • 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. PubMed 33039474 ↗
09

Updates

1 registry update since Sep 25, 2026
Primary completion
Dec 31, 2026→Dec 31, 2028
Oct 13, 2026
Study completion
Dec 31, 2026→Dec 31, 2028
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Primary completion Dec 31, 2026→Dec 31, 2028
    Study completion Dec 31, 2026→Dec 31, 2028
    + 2 other changes: verification date and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03492151
Collaborators
American College of Gastroenterology, The National Pancreas Foundation
Responsible party
Somashekar Krishna (Principal Investigator, Ohio State University) — Principal investigator
First posted
Apr 10, 2018
Start date
Oct 1, 2018
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Oct 13, 2026

Study contacts

Megan Fry
Contact
Megan.Fry@osumc.edu
614-293-1056
Diana Burke
Contact
Diana.Burke@osumc.edu
Somashekar Krishna, MD, MPH
principal investigator · Ohio State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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