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

Study Overview

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

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).

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

Pancreatic Cysts

DEVICE: Direct visualization and needle based confocal laser-induced endomicroscopy miniprobe

HS2010-7729

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-07-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-04-07
First Submitted that Met QC Criteria 2011-10-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-04-09
First Posted (ACTUAL) 2011-10-06	Results First Posted N/A	Last Verified 2021-04

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	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)	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.

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Kenneth J Chang, MD, University of California, Irvine

Publications

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

General Publications

Nakai Y, Iwashita T, Park DH, Samarasena JB, Lee JG, Chang KJ. Diagnosis of pancreatic cysts: EUS-guided, through-the-needle confocal laser-induced endomicroscopy and cystoscopy trial: DETECT study. Gastrointest Endosc. 2015 May;81(5):1204-14. doi: 10.1016/j.gie.2014.10.025. Epub 2015 Jan 26.

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Resources

PatientS

Caregivers

Clinical Trial Record