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Confocal Endomicroscopy of Pancreatic InVivo

NCT ID: NCT01035008

Last Updated: 2012-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Hypothesis: the confocal laser endomicroscopy imaging of the nCLE can differentiate between non-mucinous, mucinous non- malignant and malignant pancreatic cysts in vivo and has increased sensitivity compared to endoscopic ultrasound-fine needle aspiration (EUS-FNA) tissue sampling. In this pilot study the investigators will primarily evaluate technical feasibility and interobserver agreement.

1. In patients undergoing EUS for suspected pancreatic cysts, the investigators will evaluate the key nCLE image features of non mucinous, mucinous, and malignant pancreatic cystic neoplasms (PCN).
2. The investigators will estimate the initial image quality, feasibility, and interobserver agreement of nCLE
3. The investigators will establish the preliminary accuracy of nCLE to be used for planning a larger comparative trial

Conditions

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Pancreatic Cysts

Keywords

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pancreatic cysts

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic

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.

Group Type EXPERIMENTAL

Endoscopic Ultrasound (EUS)

Intervention Type 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.

Interventions

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Endoscopic Ultrasound (EUS)

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.

Intervention Type PROCEDURE

Other Intervention Names

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Cellvizio Endomicroscopy Confocal Endoscopic Ultrasound

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mauna Kea Technologies

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Michael B. Wallace, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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09-006345

Identifier Type: -

Identifier Source: org_study_id