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


N/A
18 Years
N/A
Not Enrolling
Both
Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic Adenoma, Pancreatic Cancer, Pancreatic Islet Cell Tumors, Lymph Node, Lymphadenopathy, GIST

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Trial Information

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


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.


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

Type of Study:

Observational [Patient Registry]

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

performance evaluation

Outcome Description:

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

Outcome Time Frame:

up to one year

Safety Issue:

No

Principal Investigator

Divyesh Sejpal, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor college of medicine, Houston

Authority:

United States: Food and Drug Administration

Study ID:

MKT_2012_nCLE_03

NCT ID:

NCT01770405

Start Date:

February 2013

Completion Date:

October 2014

Related Keywords:

  • Pancreatic Cyst
  • Pancreatic Neoplasms
  • Pancreatic Adenoma
  • Pancreatic Cancer
  • Pancreatic Islet Cell Tumors
  • Lymph Node
  • Lymphadenopathy
  • GIST
  • endomicroscopy
  • needle-based
  • pancreatic
  • cyst
  • mass
  • EUSFNA
  • Adenoma
  • Neoplasms
  • Pancreatic Cyst
  • Pancreatic Neoplasms
  • Adenoma, Islet Cell
  • Lymphatic Diseases
  • Neuroendocrine Tumors

Name

Location

Baylor College of MedicineHouston, Texas  77030
Temple University HospitalPhiladelphia, Pennsylvania  19140
Emory University HospitalAtlanta, Georgia  30322
SUNY Downstate Medical Center, New yorkNew york city, New York  11226
Sanford USD Medical CenterSioux Falls, South Dakota  57105