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

NCT01770405 | Completed

• 1 other identifier: MKT_2012_nCLE_03
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 4

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

Conditions

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

Keywords

endomicroscopy; needle-based; pancreatic; cyst; mass; EUSFNA

Outcome Measures

Primary Outcomes (1)

• performance evaluation

  * 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

  up to one year

Secondary Outcomes (1)

• Safety and feasibility evaluation

  up to one month following the procedure

Study Arms (1)

pancreatic cysts

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

Device: Endoscopic ultrasound fine needle aspiration

Interventions

Endoscopic ultrasound fine needle aspiration DEVICE

Device: nCLE needle-based Confocal Laser Endomicroscopy

Also known as: ultrasonographic endoscopy, EUS-guided FNA

pancreatic cysts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Referral patients with a clinical indication for masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract coming in for first EUS-FNA procedure at referral institution will be approached for possible inclusion into this registry

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Mauna Kea Technologies: lead

Study Sites (4)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

North Shore-LIJ Health System

Manhasset, New York, 11030, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Pancreatic Cyst; Pancreatic Neoplasms; Pancreatic adenoma; Adenoma, Islet Cell; Lymphadenopathy; Cysts; Arachnodactyly

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Neoplasms; Pancreatic Diseases; Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Endocrine System Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Lymphatic Diseases; Hemic and Lymphatic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Divyesh V Sejpal, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 17, 2013
• Study Start: September 1, 2013
• Primary Completion: December 21, 2016
• Study Completion: December 21, 2016
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

US (4)