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

NCT01563133 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2017-08-29

No results posted yet for this study

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.

Conditions

  • Pancreatic Cyst
  • Pancreatic Neoplasms
  • Pancreatic Adenoma
  • Pancreatic Cancer
  • Pancreatic Islet Cell Tumors
  • Lymph Node
  • Lymphadenopathy

Interventions

PROCEDURE

EUS-FNA

Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle

DEVICE

nCLE

needle-based Confocal Laser Endomicroscopy

Sponsors & Collaborators

  • Mauna Kea Technologies

    lead INDUSTRY

Principal Investigators

  • Marc Giovannini, MD · Institut Paoli-Calmettes

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-03-02
Completion
2019-03-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01563133 on ClinicalTrials.gov