Confocal Endomicroscopy of Pancreatic InVivo

NCT01035008 | Completed DMC

• 1 other identifier: 09-006345
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Confocal laser endomicroscopy (CLE) is a novel and highly promising imaging method for that allows in vivo imaging of the mucosal layer at resolution of approximately 1 micron. Cellular and sub-cellular structures as well as capillaries and single red blood cells can be visualized. CLE is now well established as a highly accurate method for distinguishing neoplasia in the gastrointestinal tract lumen via endoscopy. A major new breakthrough is the development of sub-millimeter CLE probes that can be passed via an image guided needle (nCLE) into solid organs and cysts. It is hypothesized that nCLE will help distinguish the benign, premalignant and malignant cystic lesions of pancreas by visualizing the cellular lining of the cysts, thereby, avoiding unnecessary surgery in patient with benign cysts and guiding to early and effective surgical removal of high risk neoplastic lesions. A prototype minimal risk nCLE system has been developed that can be passed via standard endoscopic ultrasound needles into the pancreas but FDA clearance for in vivo use is not expected until late 2010. The investigators propose to evaluate this prototype nCLE system in vivo during endoscopic ultrasound (EUS), as an initial pilot study.

Conditions

Pancreatic Cysts

Keywords

pancreatic cysts

Outcome Measures

Primary Outcomes (1)

• Differentiate between non-mucinous, mucinous non-malignant & malignant pancreatic cysts in vivo

  One day (completion of the EUS)

Study Arms (1)

Diagnostic

EXPERIMENTAL

The investigators are testing a new method called confocal laser endomicroscopy to see if it can detect pre-cancerous abnormalities in the lining of the cysts found in your pancreas. This will involve using a very thin fiber-shaped microscope which will be passed through a needle during the EUS procedure.

Procedure: Endoscopic Ultrasound (EUS)

Interventions

Endoscopic Ultrasound (EUS) PROCEDURE

The investigators will do the standard EUS procedure. If a cyst is seen in the pancreas during EUS, the investigators will administer a special dye called fluorescein through the IV, and then use the new fiber-shaped microscope to take pictures of the lining of the cysts.

Also known as: Cellvizio Endomicroscopy, Confocal, Endoscopic Ultrasound

Diagnostic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing endoscopic ultrasound for evaluation of pancreatic cysts (including pseudocysts and suspected pancreatic cystic neoplasms) in the gastrointestinal (GI) lab at Mayo Clinic Jacksonville.

You may not qualify if:

• Unwilling/unable to consent;
• Solid pancreatic mass on computerized axial tomography/magnetic resonance (CT/MR);
• Allergy to Fluorescein;
• Pregnancy.

Sponsors & Collaborators

• Mayo Clinic: lead
• Mauna Kea Technologies: collaborator

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Pancreatic Cyst

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration; Microscopy, Confocal

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Microscopy

Study Officials

• Michael B. Wallace, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 18, 2009
• Study Start: December 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 23, 2012

Record last verified: 2012-10

Locations

US (1)