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

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.

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Key information

Conditions

Pancreatic Cyst Cysts Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Scottsdale Campus, Scottsdale, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Accuracy of PCL diagnosis

Time frame: 48 months

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.
Accuracy of risk-stratification of IPMNs

Time frame: 48 months

Diagnostic accuracy of confocal laser endomicroscopy and/or composite clinical and imaging features for the risk stratification of IPMNs

Secondary outcomes

Imaging quality

Time frame: 48 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Diana Burke

CONTACT

[email protected]

Megan Fry

CONTACT

[email protected]

614-293-1056

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

American College of Gastroenterology
The National Pancreas Foundation

Registry information

Acronym: CLIMB

Important dates

Study start: 2018
Primary completion: 2026
Study completion: 2026
First posted: Apr 10, 2018
Registry last updated: Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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