Skip to main content
OpenTrials
Completed

NCT Number: NCT01035008

Confocal Endomicroscopy of Pancreatic InVivo

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreatic Cysts Cysts Digestive System Diseases Neoplasms Pancreatic Cyst Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

About this study

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.

  • 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).
  • The investigators will estimate the initial image quality, feasibility, and interobserver agreement of nCLE
  • The investigators will establish the preliminary accuracy of nCLE to be used for planning a larger comparative trial

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Cellvizio Endomicroscopy, Confocal, Endoscopic Ultrasound

Primary outcomes

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

    Time frame: One day (completion of the EUS)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Mauna Kea Technologies

Registry information

Official study title

Detection of Neoplastic Pancreatic Cysts Using Probe Based Confocal Laser Endomicroscopy: A Prospective in Vivo Study

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 18, 2009
Registry last updated
Oct 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.