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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03492151
Recruitment Status : Not yet recruiting
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
American College of Gastroenterology
The National Pancreas Foundation
Information provided by (Responsible Party):
Somashekar Krishna, Ohio State University

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.

Condition or disease
Pancreatic Cyst

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Confocal Laser Endomicroscopy as an IMaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Imaging quality [ Time Frame: 48 months ]
    Optimal quality of imaging obtained during in vivo confocal laser endomicroscopy of pancreatic cystic lesions

Biospecimen Retention:   Samples Without DNA
Pancreas cyst fluid from EUS-nCLE

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03492151

Contact: Casey McClurkin, BS, CCRC 614-688-9575
Contact: Brianna Conley, BS 614-366-4495

Sponsors and Collaborators
Ohio State University
American College of Gastroenterology
The National Pancreas Foundation
Principal Investigator: Somashekar Krishna, MD, MPH The Ohio State University Wexner Medical Center

Responsible Party: Somashekar Krishna, Assistant Professor, Ohio State University Identifier: NCT03492151     History of Changes
Other Study ID Numbers: 2017C0192
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Somashekar Krishna, Ohio State University:
Confocal laser endomicroscopy

Additional relevant MeSH terms:
Pancreatic Cyst
Pancreatic Diseases
Digestive System Diseases