Clinical trial NCT01770405: Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract
Official title: Registry Trial for Clinical Evaluation of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cyst
Pancreatic Neoplasms
Pancreatic Adenoma
Pancreatic Cancer
Pancreatic Islet Cell Tumors
Lymph Node Mass
Lymphadenopathy
GIST
Keywords: endomicroscopy
needle-based
pancreatic
cyst
mass
EUSFNA
Lead sponsor: Mauna Kea Technologies
Sponsor class: INDUSTRY
First posted: 2013-01-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Referral patients with a clinical indication for masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract coming in for first EUS-FNA procedure at referral institution will be approached for possible inclusion into this registry

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* - 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

Exclusion Criteria:

* - 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

Primary outcomes:
measure: performance evaluation
timeFrame: up to one year
Secondary outcomes:
measure: Safety and feasibility evaluation
timeFrame: up to one month following the procedure
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Manhasset
country: United States
facility: North Shore-LIJ Health System
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Northwell Health
name: Divyesh V Sejpal, MD
role: PRINCIPAL_INVESTIGATOR
References: