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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Clinical Evaluation Of NCLE in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas

Brief Summary:

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.

Detailed Summary:

  1. 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:

    • Pseudocysts
    • Serous cysts : either serous cystic neoplasms (SCN) or Solid pseudo-papillary neoplasm (SPN)
    • Mucinous cystic neoplasms : either Intraductal Papillary Mucinous Neoplasm (IPMN) or mucinous cystadenomas/mucinous cystadenocarcinoma(MCN) Mucinous cystic neoplasms are considered to be malignant or pre-malignant and are considered for surgical resection, whereas pseudocysts and serous cysts are considered benign and with a low potential for malignancy. Pseudocysts and serous cysts are usually only considered for surgical resection when symptomatic or enlarging.

    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 c
    Sponsor: Mauna Kea Technologies

    Current Primary Outcome:

    • 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 ]


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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 ]


    Original Secondary Outcome: Same as current

    Information By: Mauna Kea Technologies

    Dates:
    Date Received: March 22, 2012
    Date Started: June 2012
    Date Completion: June 2017
    Last Updated: April 5, 2016
    Last Verified: April 2016