Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract

NCT ID: NCT01770405

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-12-21

Brief Summary

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

Detailed Description

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.

Conditions

Pancreatic Cyst; Pancreatic Neoplasms; Pancreatic Adenoma; Pancreatic Cancer; Pancreatic Islet Cell Tumors; Lymph Node Mass; Lymphadenopathy; GIST

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

pancreatic cysts

Patient indicated for a first endoscopic ultrasound fine needle aspiration (EUS-FNA) for a pancreatic cyst,

Endoscopic ultrasound fine needle aspiration

Intervention Type: DEVICE

Device: nCLE needle-based Confocal Laser Endomicroscopy

Interventions

Endoscopic ultrasound fine needle aspiration

Device: nCLE needle-based Confocal Laser Endomicroscopy

Intervention Type: DEVICE

Other Intervention Names

ultrasonographic endoscopy; EUS-guided FNA

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mauna Kea Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Divyesh V Sejpal, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Emory University Hospital

Atlanta, Georgia, United States

North Shore-LIJ Health System

Manhasset, New York, United States

Columbia University Medical Center

New York, New York, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

MKT_2012_nCLE_03

Identifier Type: -

Identifier Source: org_study_id