Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound With Fine Needle Aspiration (EUS/FNA), Direct Visualization, and Confocal Laser-induced Endomicroscopy—A Pilot Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University of California, Irvine.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Kenneth J. Chang, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01447238
First received: July 14, 2011
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to assess the yield of combination modalities in the diagnosis of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (nCLE).


Condition Intervention
Pancreatic Cysts
Device: Direct visualization and needle based confocal laser-induced endomicroscopy miniprobe

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound With Fine Needle Aspiration (EUS/FNA), Direct Visualization, and Confocal Laser-induced Endomicroscopy—A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Assess the yield of combination modalities in the diagnosis of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (nCLE) [ Time Frame: From the date of imaging until follow up for 6 months to two years. ] [ Designated as safety issue: Yes ]
    Data will be analyzed descriptively to include patient characteristics, procedural variables, and outcomes.


Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Direct visualization and needle based confocal laser-induced endomicroscopy miniprobe

    Patients will undergo the EUS-FNA procedure, as per standard of care, plus an additional direct visualization (fiber optic probe) and nCLE procedure with the prototype probes, which will add 10 minutes maximum to the EUS-FNA procedure.

    The probes will be positioned against the lining of the pancreatic cyst, and images will be acquired. After imaging, fine needle aspiration of the lesion will be performed, as usual.

    Other Names:
    • Cellvizio
    • nCLE
    • Spyglass
Detailed Description:

Data will be analyzed descriptively to include patient characteristics, procedural variables, and outcomes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients underoing EUS-FNA procedure for pancreatic cyst.

Criteria

Inclusion Criteria:

  • Patients scheduled for an EUS-FNA procedure of a pancreatic cyst,
  • Aged above 18 years
  • Granted written informed consent for the study can be included in the study.

Exclusion Criteria:

  • Contraindication for undergoing EUS/FNA procedure (such as unwilling or medically unstable patients, patients with severe coagulopathy, patients with poor visualization on EUS for various reasons, etc)
  • Pregnant or breastfeeding
  • Allergy to fluorescein
  • Renal insufficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447238

Contacts
Contact: Amy Tan 714-456-2215 amytan@uci.edu
Contact: Herlinda Bergman 714-456-7090 hbergman@uci.edu

Locations
United States, California
University of California, Irvine Medical Center Recruiting
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Kenneth J Chang, MD University of California, Irvine
  More Information

No publications provided

Responsible Party: Kenneth J. Chang, Professor of Clinical Medicine, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01447238     History of Changes
Other Study ID Numbers: HS2010-7729
Study First Received: July 14, 2011
Last Updated: October 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
pancreatic cysts
EUS/FNA
Needle-based Confocal Laser Endomicroscopy (nCLE)
fiber optic imaging
EUS/FNA of pancreatic cysts

Additional relevant MeSH terms:
Cysts
Pancreatic Cyst
Neoplasms
Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 22, 2014