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

Pancreatic Cyst Clinical Trial

— CLIMB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03492151
• Other study ID #: 2017C0192
• Status: Recruiting
• Start date: October 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Ohio State University
• Contact: Megan Fry
• Phone: 614-293-1056
• Email: Megan.Fry[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cyst

Locations

Country	Name	City	State
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Parkview Hospital Randallia	Fort Wayne	Indiana
United States	NYU Langone Health	Garden City	New York
United States	Baylor College of Medicine	Houston	Texas
United States	Yale School of Medicine	New Haven	Connecticut
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Mayo Clinic Scottsdale Campus	Scottsdale	Arizona
United States	Stanford Hospital	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	American College of Gastroenterology, The National Pancreas Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Imaging quality	Optimal quality of imaging obtained during in vivo confocal laser endomicroscopy of pancreatic cystic lesions	48 months