Clinical Registry Of NCLE In Masses And Cystic Tumors Of The Pancreas, Lymph Nodes, Submucosal Lesions Of The GI Tract

Study Overview

Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract

This study focuses on four different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract, pancreatic masses and GIST tumors. On one hand, the results obtained during previous studies are more advanced for the assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have already been performed, and an interpretation criteria classification exists. On the other hand, results for pancreatic masses, Lymph nodes and GIST are less developed. the objectives of the study are to * Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract * Define/Validate descriptive criteria of nCLE sequences in masses and cystic tu-mors of the pancreas, lymph nodes, submucosal lesions of the GI tract

The principle of needle-based Confocal Laser Endomicroscopy (nCLE) is to image organs within or adjacent to the GI or respiratory tracts by means of a miniprobe inserted through an endoscopic needle. The fundamental technology, as well as the principle of operation of nCLE, is substantially similar to pCLE. endoscopic fine needles are used during EUS-FNA procedures to puncture solid organs such as the pancreas, in order to get tissue or fluid for diagnostic purposes. There are different calibers of endoscopic nee-dles used. The most commonly used calibers for EUS-FNA procedures are 22G, 19G, and 25G needles. The nCLE Confocal Miniprobe is compatible with the 19G-type needle only. It is expected to help to differentiate the different types of lesions, especially for cysts, leading to better patient management. Microscopic tissue information in real-time in vivo during an EUS-FNA procedure may allow better differentiation between mucinous and non-mucinous cysts for instance.

Pancreatic Cyst
Pancreatic Neoplasms
Pancreatic Adenoma
Pancreatic Cancer
Pancreatic Islet Cell Tumors
Lymph Node Mass
Lymphadenopathy
GIST

DEVICE: Endoscopic ultrasound fine needle aspiration

MKT_2012_nCLE_03

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 2013-01-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-08-28
First Submitted that Met QC Criteria 2013-01-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-08-29
First Posted (ACTUAL) 2013-01-17	Results First Posted N/A	Last Verified 2017-08

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
: pancreatic cysts Patient indicated for a first endoscopic ultrasound fine needle aspiration (EUS-FNA) for a pancreatic cyst,	DEVICE: Endoscopic ultrasound fine needle aspiration Device: nCLE needle-based Confocal Laser Endomicroscopy

Participant Group/Arm

Intervention/Treatment

: pancreatic cysts

Patient indicated for a first endoscopic ultrasound fine needle aspiration (EUS-FNA) for a pancreatic cyst,

DEVICE: Endoscopic ultrasound fine needle aspiration

Device: nCLE needle-based Confocal Laser Endomicroscopy

Primary Outcome Measures	Measure Description	Time Frame
performance evaluation	* Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract (accuracy evaluation) * Define/Validate descriptive criteria for nCLE sequences in the characterization of masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract (image interpretation criteria definition	up to one year

Secondary Outcome Measures	Measure Description	Time Frame
Safety and feasibility evaluation	* Evaluate the feasibility and safety of nCLE for the characterization of masses and cystic tumors of the pan-creas, lymph nodes, submucosal lesions of the GI tract (IE. number of patients with complications, number of adverse events) * Build an atlas of images of nCLE sequences of masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract	up to one month following the procedure

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:

- Male or female > 18 years of age
Patient indicated for a first EUS-FNA for masses and cystic tumors of the pancreas, lymph nodes, submu-cosal lesions of the GI tract
Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract
Patient with known masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract
For pancreatic cyst patient, suffering chronic calcifying pancreatitis
For pancreatic mass patient, any size or location
For lymph node patient, any node reachable with EUS-FNA
Willing and able to comply with study procedures and provide written informed consent to participate in the registry

- Subjects for whom EUS-FNA procedures are contraindicated
Known allergy to fluorescein contrast
If female, breast feeding or pregnant based on a positive hCG serum or an in vitro diagnostic test result
Subject with multiple cysts
Cysts <20 mm in diameter
Previous EUS-FNA procedure performed less than 3 months ago
If several pancreatic masses, only one will be imaged during the nCLE procedure
Lymph nodes <5 mm in diameter
If several suspicious lymph nodes, only the most suspect will be imaged during the nCLE proce-dure

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Divyesh V Sejpal, MD, Northwell Health

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

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record