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A Study to Evaluate the Use of Confocal Laser Endomicroscopy as an IMaging Biomarker (CLIMB Study) for the Diagnosis of Pancreatic Cystic Lesions

Overview

About this study

The purpose of this study is to evaluate EUS-nCLE as an imaging biomarker and PCL fluid DNA analysis as a molecular biomarker for the management of pancreatic cystic lesions (PCLs).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patient age 18 years and older.
  • All patients referred for EUS-FNA of accessible PCL where surgery is contemplated.
  • Symptomatic from their pancreatic cyst.
  • Side branch cyst along with main duct involvement (mixed main duct- side branch IPMN).
  • Presence of mural nodules in cyst.
  • At least one cyst greater than 2 cm in size.
  • Surgeon decision for resection of cyst.
  • The minimum size of the cyst 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Rahul Pannala, M.D.

Open for enrollment

Contact information:

Rahul Pannala M.D.

(480)301-8374

Pannala.Rahul@mayo.edu

More information

Publications

Publications are currently not available

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CLS-20467338

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