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Needle-based Confocal Endomicroscopy Examination of Pancreatic Masse

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ClinicalTrials.gov Identifier: NCT01734967
Recruitment Status : Recruiting
First Posted : November 28, 2012
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Introduction: Pancreatic cancer is one of the most aggressive malignancies with only 5% of patients being alive at five years. EUS (endoscopic ultra sound) is an established, sensitive diagnostic tool in pancreatic cancer and for staging purposes. Additionally, EUS enables guided fine needle aspiration (FNA), which is currently recommended as the first-line procedure whenever a pathological diagnosis is required. However, EUS-FNA as a sampling method has its drawbacks, due to a relatively low negative predictive value. Confocal laser endomicroscopy has emerged in recent years as a novel method that enables in vivo microscopic analysis during ongoing endoscopy. Recently, confocal laser endomicroscopy has gone beyond the superficial luminal indications with the development of a new microprobe, i.e. a flexible laser probe (nCLE) that can pass through a 19-gauge needle. Combined with EUS, descriptive criteria for the diagnosis of pancreatic cystic neoplasm has been developed in a multicentre trial. However, only a limited number of cases of solid pancreatic masses have been described with nCLE.

Aim and Method: To describe confocal imaging criteria for pancreatic masses, lymph nodes or liver metastases identified during EUS procedures performed for pancreatic cancer staging (EUS-nCLE), while evaluating also the feasibility and safety of nCLE examination. The hypothesis is that EUS-nCLE could allow targeted tissue sampling of pancreatic lesions resulting in more accurate diagnosis. XX patients were included all presenting with a clinical suspicion of pancreatic cancer or imaging studies showing a pancreatic mass. During the procedure an nCLE preloaded 19G FNA needle was advanced into the lesion under EUS guidance. A contrast agent was administered intravenously (2.5 ml fluorescein 10%). The data was stored digitally for post procedural analysis. Afterwards EUS-FNA was performed for cytology smears to enable a final pathological diagnosis. Correlations between the nCLE images and the conventional pathology were identified.


Condition or disease Intervention/treatment
Pancreatic Neoplasms CHRONIC PANCREATITIS Device: needle based CLE Procedure: EUS-FNA

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Needle-based Confocal Endomicroscopy Examination of Pancreatic Masses
Study Start Date : November 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: needle based CLE & EUS-FNA
The study will prospectively include patients referred to our department for EUS and EUS-FNA of suspected pancreatic masses during a 12 months period. The indication for this investigation will be based on the patient's clinical history and previous imaging studies (abdominal ultrasound, CT scan, MRI).
Device: needle based CLE

EUS-nCLE will be performed after EUS identification of the pancreatic tumor / lymph node / liver metastasis:

The confocal microprobe will be preloaded in a 19G FNA needle as previously described and advanced into the lesion under EUS guidance.

nCLE examination will follow after the intravenous administration of the contrast agent (2.5 ml fluorescein 10%).

Image data will be stored digitally for offline analysis.

Other Name: nCLE
Procedure: EUS-FNA
Endoscopic ultrasound (EUS) is an established tool in pancreatic masses used both for diagnosis, but also for staging purposes. Additionally, EUS enables guided fine needle aspiration (FNA), which is currently recommended as the first-line procedure whenever a pathological diagnosis is required.
Other Name: Endoscopic ultrasound with fine-needle aspiration


Outcome Measures

Primary Outcome Measures :
  1. Describe confocal imaging criteria for pancreatic masses, lymph nodes or liver metastases [ Time Frame: 6 month ]

    Tumor characteristics (EUS) (echogenicity, echostructure, size, vascular invasion) will be described.

    EUS-nCLE will be performed after EUS identification of the pancreatic tumor / lymph node / liver metastasis:

    Confocal images will be analyzed to correlate representative confocal images and classical hematoxylin and eosin sections.

    The final diagnosis will be based on EUS-FNA cytology and/or histological specimens in those patients that will be further referred for surgery. For the patients without positive cytology or histology the diagnosis will be based on EUS tumor characteristics and other relevant information (clinical, imaging tests) with follow-up for at least six months

    The outcome is fully descriptive.



Secondary Outcome Measures :
  1. Safety [ Time Frame: 30 days ]
    Number of adverse events related til the procedure

  2. Feasibility [ Time Frame: 1 day ]
    Feasibility of nCLE examination measured by the number of patients, where nCLE is accomplished


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • Age > 18 years old, male or female
  • Patients diagnosed with solid pancreatic masses with an indication for EUS-FNA
  • Signed informed consent for EUS with FNA and nCLE examination

Exclusion criteria

  • Failure to provide informed consent
  • Patients with a contraindication for EUS-FNA
  • Known allergy to fluorescein
  • Pregnant or breast-feeding patients
Contacts and Locations

Information from the National Library of Medicine

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): NCT01734967


Contacts
Contact: John G Karstensen, M.D. +45 38681358 john.gasdal.karstensen.01@regionh.dk
Contact: Peter Vilmann, Prof. + 45 61677950 peter.vilmann@regionh.dk

Locations
Denmark
Copenhagen University Hospital Herlev Recruiting
Herlev, Denmark, 2730
Contact: John G Karstensen, M.D.    +45 38681358    john.gasdal.karstensen.01@regionh.dk   
Contact: Peter Vilmann, Prof.    +61677950    peter.vilmann@regionh.dk   
Principal Investigator: John G Karstensen, M.D.         
Romania
Research Center of Gastroenterology and Hepatology, Recruiting
Craiva, Romania, 200349,
Contact: Adrian Saftoiu, Prof.    40 744 823355    adriansaftoiu@aim.com   
Principal Investigator: Adrian saftoiu, Prof.         
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: john G Karstensen, M.D. Copenhagen University Hospital at Herlev
More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Gasdal Karstensen, M.D., Herlev Hospital
ClinicalTrials.gov Identifier: NCT01734967     History of Changes
Other Study ID Numbers: herlev
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017

Keywords provided by John Gasdal Karstensen, Herlev Hospital:
confocal laser endomicroscopy
Pancreatic Neoplasms
CHRONIC PANCREATITIS
Endoscopic ultrasound

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Neoplasms
Pancreatic Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases