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

April 7, 2021 updated by: University of California, Irvine
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients underoing EUS-FNA procedure for pancreatic cyst.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Data will be analyzed descriptively to include patient characteristics, procedural variables, and outcomes.
From the date of imaging until follow up for 6 months to two years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Kenneth J Chang, MD, University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2010

Primary Completion (Actual)

September 21, 2018

Study Completion (Actual)

September 21, 2018

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimate)

October 6, 2011

Study Record Updates

Last Update Posted (Actual)

April 9, 2021

Last Update Submitted That Met QC Criteria

April 7, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS2010-7729

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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