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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Registry Trial for Clinical Evaluation of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract

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

Intervention / Treatment
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* Device: Endoscopic ultrasound fine needle aspiration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pancreatic cysts<br>Patient indicated for a first endoscopic ultrasound fine needle aspiration (EUS-FNA) for a pancreatic cyst, | Device: Endoscopic ultrasound fine needle aspiration<br>* Device: nCLE needle-based Confocal Laser Endomicroscopy<br>* Other names: EUS-guided FNA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endomicroscopy, needle-based, pancreatic, cyst, mass, EUSFNA