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A Phase II MULTICENTRE Trial of Needle Based Laser Confocal Endomicroscopy of Cystic and Solid Tumours of the Pancreas (CONCYST)

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ClinicalTrials.gov Identifier: NCT02523170
Recruitment Status : Unknown
Verified October 2016 by University College, London.
Recruitment status was:  Recruiting
First Posted : August 14, 2015
Last Update Posted : May 4, 2017
Sponsor:
Collaborator:
Cambridge University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
University College, London

Brief Summary:
A multicentre phase II study to determine the safety and efficacy of EUS-guided nCLE in patients with suspected cystic tumours of the pancreas in whom endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is clinically indicated. Patients will be recruited sequentially to undergo nCLE as part of their routine diagnostic evaluation, followed by standard surveillance. This part of the study will recruit 60 patients.

Condition or disease Intervention/treatment Phase
Pancreatic Cyst Serous Cystadenoma Intraductal Papillary Mucinous Neoplasm Cystadenoma, Mucinous Device: AQ-Flex 19 probe (Mauna Kea Technologies, Paris) Not Applicable

Detailed Description:

A multicentre phase II study to determine the safety and efficacy of EUS-guided nCLE in patients with suspected cystic tumours of the pancreas in whom endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is clinically indicated. Patients will be recruited sequentially to undergo nCLE as part of their routine diagnostic evaluation, followed by standard surveillance. This part of the study will recruit 60 patients. The study also includes a feasibility study to evaluate the role of intraoperative nCLE in the diagnosis and staging of pancreatic tumours. This part of the study will recruit a further 20 patients.

Primary endpoint:

Assess the diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts, compared to standard diagnostic modalities.

Secondary endpoints:

  • Assess the safety and efficacy of EUS-nCLE.
  • Assess the impact of the Cellvizio nCLE system on the management of patients with pancreatic cysts.
  • Develop and validate interpretation criteria for nCLE in the pancreas.
  • Assess the diagnostic performance of nCLE in characterising and staging pancreatic tumours intraoperatively.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase II MULTICENTRE Trial of Needle Based Laser Confocal Endomicroscopy of Cystic and Solid Tumours of the Pancreas
Study Start Date : July 2014
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EUS guided nCLE
For patients with indeterminate cystic lesions of the pancreas, in addition to routine diagnostic investigations, patients participating in the study will undergo needle based confocal laser endomicroscopy (using the AQ-flex 19 probe - Mauna Kea Technologies, Paris France) at the time of their endoscopic ultrasound.
Device: AQ-Flex 19 probe (Mauna Kea Technologies, Paris)
Needle-based Confocal Laser Endomicroscopy (nCLE)




Primary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: 3 years ]
    Assess the diagnostic accuracy of the Cellvizio nCLE system for diagnosing cystic lesions of the pancreas, compared to standard diagnostic modalities


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 3 years ]
    Record the number of participants with an adverse event due to EUS-nCLE

  2. Interpretation criteria [ Time Frame: 3 years ]
    Develop and validate interpretation criteria for nCLE in the pancreas

  3. Assess margins [ Time Frame: 3 years ]
    Assess the diagnostic accuracy of nCLE in defining the margins and extent of pancreatic tumours intraoperatively



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A diagnosis of a pancreatic cystic tumour based on multidisciplinary review of imaging for which EUS-FNA is indicated.
  2. Pancreatic cystic tumour >1cm in size.
  3. ECOG performance status 0, 1 or 2.
  4. Estimated life expectancy of at least 12 weeks.
  5. Age >18 years.
  6. Capable of giving written informed consent.
  7. Has not has pancreatitis within the previous 3 months.
  8. Women of child-bearing potential must have a negative pregnancy test in the week before nCLE, AND be using an adequate contraception method, which must be continued for at least 1 week after nCLE.

Exclusion Criteria:

  1. Acute pancreatitis in the last 3 months.
  2. Subject with multiple cysts
  3. Subjects for whom EUS-FNA or surgery are contraindicated
  4. Known allergy to fluorescein dye
  5. Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial.
  6. Any psychiatric disorder making reliable informed consent impossible.
  7. Pregnancy or breast-feeding.
  8. ECOG performance status 3 or 4

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): NCT02523170


Contacts
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Contact: Steve Pereira, PhD FRCP stephen.pereira@ucl.ac.uk
Contact: Geri Keane, MSc MRCP geri.keane.09@ucl.ac.uk

Locations
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United Kingdom
Addenbrooks Hospital Terminated
Cambridge, United Kingdom
Royal Free Hospital Recruiting
London, United Kingdom
Contact: Steve Pereira, PhD FRCP       stephen.pereira@ucl.ac.uk   
University College London Hospitals Recruiting
London, United Kingdom
Contact: Steve Pereira, PhD FRCP       stephen.pereira@ucl.ac.uk   
Freeman Hospital Recruiting
Newcastle, United Kingdom
Contact: Kofi Oppong       Kofi.Oppong@nuth.nhs.uk   
Sponsors and Collaborators
University College, London
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Steve Pereira, PhD FRCP University College, London

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02523170     History of Changes
Other Study ID Numbers: 13/0572
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: October 2016

Additional relevant MeSH terms:
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Pancreatic Cyst
Pancreatic Neoplasms
Cystadenoma
Cystadenoma, Serous
Cystadenoma, Mucinous
Cysts
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
Neoplasms, Cystic, Mucinous, and Serous
Pancrelipase
Pancreatin
Gastrointestinal Agents