Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract (US-nCLE)
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ClinicalTrials.gov Identifier: NCT01770405 |
Recruitment Status
:
Completed
First Posted
: January 17, 2013
Last Update Posted
: August 29, 2017
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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
- Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract
- Define/Validate descriptive criteria of nCLE sequences in masses and cystic tu-mors of the pancreas, lymph nodes, submucosal lesions of the GI tract
Condition or disease | Intervention/treatment |
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Pancreatic Cyst Pancreatic Neoplasms Pancreatic Adenoma Pancreatic Cancer Pancreatic Islet Cell Tumors Lymph Node Mass Lymphadenopathy GIST | Device: Endoscopic ultrasound fine needle aspiration |
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.
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 40 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Year |
Official Title: | Registry Trial for Clinical Evaluation of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract |
Study Start Date : | September 2013 |
Actual Primary Completion Date : | December 21, 2016 |
Actual Study Completion Date : | December 21, 2016 |

Group/Cohort | Intervention/treatment |
---|---|
pancreatic cysts
Patient indicated for a first endoscopic ultrasound fine needle aspiration (EUS-FNA) for a pancreatic cyst,
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Device: Endoscopic ultrasound fine needle aspiration
Device: nCLE needle-based Confocal Laser Endomicroscopy
Other Names:
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- performance evaluation [ Time Frame: up to one year ]
- Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract (accuracy evaluation)
- Define/Validate descriptive criteria for nCLE sequences in the characterization of masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract (image interpretation criteria definition
- Safety and feasibility evaluation [ Time Frame: up to one month following the procedure ]
- Evaluate the feasibility and safety of nCLE for the characterization of masses and cystic tumors of the pan-creas, lymph nodes, submucosal lesions of the GI tract (IE. number of patients with complications, number of adverse events)
- Build an atlas of images of nCLE sequences of masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- - Male or female > 18 years of age
- Patient indicated for a first EUS-FNA for masses and cystic tumors of the pancreas, lymph nodes, submu-cosal lesions of the GI tract
- Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract
- Patient with known masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract
- For pancreatic cyst patient, suffering chronic calcifying pancreatitis
- For pancreatic mass patient, any size or location
- For lymph node patient, any node reachable with EUS-FNA
- Willing and able to comply with study procedures and provide written informed consent to participate in the registry
Exclusion Criteria:
- - Subjects for whom EUS-FNA procedures are contraindicated
- Known allergy to fluorescein contrast
- If female, breast feeding or pregnant based on a positive hCG serum or an in vitro diagnostic test result
- Subject with multiple cysts
- Cysts <20 mm in diameter
- Previous EUS-FNA procedure performed less than 3 months ago
- If several pancreatic masses, only one will be imaged during the nCLE procedure
- Lymph nodes <5 mm in diameter
- If several suspicious lymph nodes, only the most suspect will be imaged during the nCLE proce-dure

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770405
United States, Georgia | |
Emory University Hospital | |
Atlanta, Georgia, United States, 30322 | |
United States, New York | |
North Shore-LIJ Health System | |
Manhasset, New York, United States, 11030 | |
Columbia University Medical Center | |
New York, New York, United States, 10032 | |
United States, Pennsylvania | |
Temple University Hospital | |
Philadelphia, Pennsylvania, United States, 19140 |
Principal Investigator: | Divyesh V Sejpal, MD | Northwell Health |
Responsible Party: | Mauna Kea Technologies |
ClinicalTrials.gov Identifier: | NCT01770405 History of Changes |
Other Study ID Numbers: |
MKT_2012_nCLE_03 |
First Posted: | January 17, 2013 Key Record Dates |
Last Update Posted: | August 29, 2017 |
Last Verified: | August 2017 |
Keywords provided by Mauna Kea Technologies:
endomicroscopy needle-based pancreatic |
cyst mass EUSFNA |
Additional relevant MeSH terms:
Pancreatic Neoplasms Adenoma Lymphadenopathy Pancreatic Cyst Adenoma, Islet Cell Neuroendocrine Tumors Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases |
Pancreatic Diseases Endocrine System Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Lymphatic Diseases Cysts Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Pancrelipase Gastrointestinal Agents |