Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas (CONTACT)
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.
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.
- 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.
Pancreatic Islet Cell Tumors
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Clinical Evaluation Of NCLE in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas|
- Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts [ Time Frame: Within 6 months after the end of Follow-up period ] [ Designated as safety issue: No ]
- Descriptive criteria in nCLE sequences for the characterization of pancreatic masses and lymph nodes [ Time Frame: Within one year after the end of the follow-up period ] [ Designated as safety issue: No ]
- Impact of the Cellvizio nCLE system on the management of a patient with pancreatic cyst [ Time Frame: Within one year after the end of the follow-up period ] [ Designated as safety issue: No ]
- Validation of the interpretation criteria classification for pancreatic cysts [ Time Frame: within 6 months after the end of the follow-up period ] [ Designated as safety issue: No ]
- Atlas of images of nCLE sequences of pancreatic masses and lymph nodes during EUS-FNA [ Time Frame: within 3 months of the end of the follow-up period ] [ Designated as safety issue: No ]
- Diagnostic performance of nCLE in the diagnosis of pancreatic masses and lymph nodes, when associated with other diagnostic information [ Time Frame: within one year after the end of the follow-up period ] [ Designated as safety issue: No ]
- Feasibility and safety data on nCLE during EUS-FNA procedure [ Time Frame: Within 3 months after the end of the enrollment period ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Lymph nodes, pancreatic masses & cysts||
Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle
Other Names:Device: nCLE
needle-based Confocal Laser Endomicroscopy
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|Contact: Marc Giovannini, MDemail@example.com|
|Lomme, France, 59462|
|Sub-Investigator: Bernard Filoche, MD, PhD|
|Principal Investigator: Damien Lucidarme, MD, PhD|
|Hôpital Jean Mermoz||Recruiting|
|Lyon, France, 69008|
|Principal Investigator: Bertrand Napoléon, MD|
|Sub-Investigator: Bertrand Pujol|
|Institut Paoli Calmettes||Recruiting|
|Marseille, France, 13273|
|Principal Investigator: Marc Giovannini, MD|
|Sub-Investigator: Fabrice Caillol|
|Principal Investigator:||Marc Giovannini, MD||Institut Paoli-Calmettes|