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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pancreatic cysts | Patient indicated for a first endoscopic ultrasound fine needle aspiration (EUS-FNA) for a pancreatic cyst, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic ultrasound fine needle aspiration | Device | Device: nCLE needle-based Confocal Laser Endomicroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| performance evaluation |
| up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and feasibility evaluation |
|
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Divyesh V Sejpal, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States | ||
| North Shore-LIJ Health System |
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| up to one month following the procedure |
| Manhasset |
| New York |
| 11030 |
| United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| ID | Term |
|---|---|
| D010181 | Pancreatic Cyst |
| D010190 | Pancreatic Neoplasms |
| C538110 | Pancreatic adenoma |
| D007516 | Adenoma, Islet Cell |
| D000072281 | Lymphadenopathy |
| D003560 | Cysts |
| D054119 | Arachnodactyly |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D061765 | Endoscopic Ultrasound-Guided Fine Needle Aspiration |
| ID | Term |
|---|---|
| D044963 | Biopsy, Fine-Needle |
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D061705 | Image-Guided Biopsy |
| D013048 | Specimen Handling |
| D018084 | Ultrasonography, Interventional |
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
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