Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas

This study focuses on three different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract and pancreatic masses. 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 and Lymph nodes are less developed. The study therefore comprises two sub-studies, one on the pancreatic cysts, and another on pancreatic masses and lymph nodes. 1. Cysts The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making. For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by : * Ruling out malignancy for patients with benign appearing nCLE images. * Characterizing more malignant tumors in the pancreas. 2. Pancreatic masses and Lymph nodes The primary hypothesis of the study is that in vivo imaging of lymph-nodes near the gastrointestinal tract and pancreatic masses during EUS-FNA procedures is feasible and that descriptive criteria can be defined to further differentiate the different types of lesions.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Male or female \> 18 years of age.
* Patient indicated for a first EUS-FNA for a pancreatic cyst, lymph node or pancreatic mass, or
* Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for pancreatic cyst, lymph nodes, pancreatic mass, more than three months ago.
* Patient with known pancreatic cyst or mass detected at cross-sectional imaging or suspicious lymph nodes reachable via EUSFNA
* Willing and able to comply with study procedures and provide written informed consent to participate in the study.

Add for lymph nodes:

\- any lymph node reachable with EUS-FNA

Add for pancreatic mass:

* any size
* any location in the pancreas

Exclusion Criteria:

* Subjects for whom EUS-FNA procedures are contraindicated
* Known allergy to fluorescein dye
* If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding

Add for cysts:

* Subject with multiple cysts
* size \< 20mm in diameter
* previous EUS-FNA procedure performed less than 3 months ago - Patients suffering chronic calcifying pancreatitis

Add for lymph nodes:

* size \< 5mm in diameter
* If patients present several suspicious lymph nodes, only one of them will be imaged during the nCLE procedure

Add for pancreatic mass:

\- If patient present several pancreatic masses, only one of them will be imaged during the nCLE procedure

• BACKGROUNDAdsay NV. Cystic neoplasia of the pancreas: pathology and biology. J Gastrointest Surg. 2008 Mar;12(3):401-4. doi: 10.1007/s11605-007-0348-z. Epub 2007 Oct 24. PMID 17957438
• BACKGROUNDLevy MJ, Clain JE. Evaluation and management of cystic pancreatic tumors: emphasis on the role of EUS FNA. Clin Gastroenterol Hepatol. 2004 Aug;2(8):639-53. doi: 10.1016/s1542-3565(04)00235-6. PMID 15290655
• BACKGROUNDHutchins GF, Draganov PV. Cystic neoplasms of the pancreas: a diagnostic challenge. World J Gastroenterol. 2009 Jan 7;15(1):48-54. doi: 10.3748/wjg.15.48. PMID 19115467
• BACKGROUNDAttasaranya S, Pais S, LeBlanc J, McHenry L, Sherman S, DeWitt JM. Endoscopic ultrasound-guided fine needle aspiration and cyst fluid analysis for pancreatic cysts. JOP. 2007 Sep 7;8(5):553-63. PMID 17873459
• BACKGROUNDBecker V, Vercauteren T, von Weyhern CH, Prinz C, Schmid RM, Meining A. High-resolution miniprobe-based confocal microscopy in combination with video mosaicing (with video). Gastrointest Endosc. 2007 Nov;66(5):1001-7. doi: 10.1016/j.gie.2007.04.015. Epub 2007 Sep 4. PMID 17767932
• BACKGROUNDMeining A, Saur D, Bajbouj M, Becker V, Peltier E, Hofler H, von Weyhern CH, Schmid RM, Prinz C. In vivo histopathology for detection of gastrointestinal neoplasia with a portable, confocal miniprobe: an examiner blinded analysis. Clin Gastroenterol Hepatol. 2007 Nov;5(11):1261-7. doi: 10.1016/j.cgh.2007.05.019. Epub 2007 Aug 6. PMID 17689297
• BACKGROUNDKiesslich R, Gossner L, Goetz M, Dahlmann A, Vieth M, Stolte M, Hoffman A, Jung M, Nafe B, Galle PR, Neurath MF. In vivo histology of Barrett's esophagus and associated neoplasia by confocal laser endomicroscopy. Clin Gastroenterol Hepatol. 2006 Aug;4(8):979-87. doi: 10.1016/j.cgh.2006.05.010. Epub 2006 Jul 13.