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

September 30, 2019 updated by: University College, London
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom
        • Addenbrookes Hospital
      • London, United Kingdom
        • Royal Free Hospital
      • London, United Kingdom
        • University College London Hospitals
      • Newcastle, United Kingdom
        • Freeman Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 3 years
Record the number of participants with an adverse event due to EUS-nCLE
3 years
Interpretation criteria
Time Frame: 3 years
Develop and validate interpretation criteria for nCLE in the pancreas
3 years
Assess margins
Time Frame: 3 years
Assess the diagnostic accuracy of nCLE in defining the margins and extent of pancreatic tumours intraoperatively
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Cambridge University Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: Steve Pereira, PhD FRCP, University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2014

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

April 1, 2018

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (ESTIMATE)

August 14, 2015

Study Record Updates

Last Update Posted (ACTUAL)

October 2, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/0572

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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