An interventional study of EUS-FNA and nCLE in Pancreatic Cyst, Pancreatic Neoplasms and Pancreatic Adenoma, sponsored by Mauna Kea Technologies. Status unknown at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-29.
Sponsored by Mauna Kea Technologies · Not applicable, Interventional, and Diagnostic
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 :
Medical background Pancreatic cancer is the fourth leading cause of cancer-related death in the United States. This disease is associated with a high mortality rate: the 5-year survival rate is estimated to be 4%. This is mainly due to the fact that the disease is often discovered at an already advanced disease state, which carries a dismal prognosis.
1.1. Pancreatic Cysts
Pancreatic cysts are quite rare, but are being increasingly recognized due to the expanding use of cross-sectional imaging. They are classified into three main classes:
1.2. Pancreatic masses Pancreatic solid masses can be either exocrine or endocrine tumors, or metastatic.Exocrine tumors are by far the most common type of pancreas cancer. Most of them are malignant. About 96% of cancers of the exocrine pancreas are adenocarcinomas, which is the most aggressive form of pancreas cancer.Endocrine tumors are uncommon. They represent 4% of pancreas tumors. They are known as neuroendocrine tumors (NETs), or islet cell tumors. These tumors can be benign or malignant.
1.3. Lymph nodes Lymph nodes are examined in a patient with a suspicion of, or confirmed, cancer, as part of the staging. They may be either normal, inflammatory, or malignant.
Clinical background
2.1. EUSFNA Endoscopic Ultrasound (EUS) is the diagnostic method of choice when a pancreatic lesion is found incidentally on cross-sectional imaging. Endoscopic UltraSound-guided Fine Needle Aspiration (EUS FNA) (respectively Endobronchial Ultrasound-guided Fine Needle Aspiration (EBUS FNA)) are procedures where a target tissue in proximity to the GI tract (respectively the pulmonary tract) is biopsied using a fine needle guided in real time by an ultrasound probe fixed at the tip of an endoscope.It may therefore be applied to pancreatic lesions, or lymph nodes examination.
2.2. nCLE The principle of needle-based Confocal Laser Endomicroscopy (nCLE) is to image organs within or adjacent to the GI or respiratory tracts with a miniprobe inserted through an endoscopic needle. The fundamental technology as well as the principle of operation of nCLE are substantially similar to pCLE.
Objectives
4.1. Cysts 4.1.1. The primary objective of the study is to assess the diagnostic performance of the Cellvizio nCLE system in diagnosing pancreatic cysts, when associated with other diagnostic information.
4.1.2. The secondary objectives are to assess the potential impact of the Cellvizio nCLE system on patient management and validate the interpretation classification criteria that were created during the previous INSPECT study on cysts.
4.2. Pancreatic masses and Lymph nodes 4.2.1. The primary objective of the study is to define criteria of nCLE sequences in lymph nodes and pancreatic masses.
4.2.2. The secondary objectives are to evaluate feasibility and safety of the Cellvizio nCLE during EUS-FNA procedures, build an atlas of images of nCLE sequences of pancreatic masses and lymph nodes, and, finally, retrospectively assess the diagnostic performance of nCLE in the diagnosis of pancreatic masses and lymph nodes, when associated with other diagnostic information
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 330 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Mauna Kea Technologies is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Add for lymph nodes:
Add for pancreatic mass:
Exclusion Criteria:
Add for cysts:
Add for lymph nodes:
Add for pancreatic mass:
Procedure: EUS-FNA · Device: nCLE
Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle
Also known as: ultrasonographic endoscopy, EUS-guided FNA
needle-based Confocal Laser Endomicroscopy
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
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
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
Validation of the interpretation criteria classification for pancreatic cysts
Time frame: within 6 months after the end of the follow-up period
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
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
Feasibility and safety data on nCLE during EUS-FNA procedure
Time frame: Within 3 months after the end of the enrollment period
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