Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Needle-based Confocal Endomicroscopy Examination of Pancreatic Masse

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Herlev Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
John Gasdal Karstensen, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01734967
First received: November 19, 2012
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

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 Intervention
Pancreatic Neoplasms
CHRONIC PANCREATITIS
Device: needle based CLE
Procedure: EUS-FNA

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Needle-based Confocal Endomicroscopy Examination of Pancreatic Masses

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Describe confocal imaging criteria for pancreatic masses, lymph nodes or liver metastases [ Time Frame: 6 month ] [ Designated as safety issue: No ]

    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:
  • Safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Number of adverse events related til the procedure

  • Feasibility [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Feasibility of nCLE examination measured by the number of patients, where nCLE is accomplished


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Responsible Party: John Gasdal Karstensen, M.D., Herlev Hospital
ClinicalTrials.gov Identifier: NCT01734967     History of Changes
Other Study ID Numbers: herlev
Study First Received: November 19, 2012
Last Updated: November 28, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Herlev Hospital:
confocal laser endomicroscopy
Pancreatic Neoplasms
CHRONIC PANCREATITIS
Endoscopic ultrasound

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

ClinicalTrials.gov processed this record on November 27, 2014