Pancreatic CystCONCYSTNCT02523170
A Phase II MULTICENTRE Trial of Needle Based Laser Confocal Endomicroscopy of Cystic and Solid Tumours of the Pancreas
A study testing AQ-Flex 19 probe (Mauna Kea Technologies, Paris) in people with Pancreatic Cyst and Serous Cystadenoma, run by University College, London at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cyst, Serous Cystadenoma, Intraductal Papillary Mucinous Neoplasm
- What is being tested?
- AQ-Flex 19 probe (Mauna Kea Technologies, Paris)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Jul 2014to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of a pancreatic cystic tumour based on multidisciplinary review of imaging for which EUS-FNA is indicated.
- Pancreatic cystic tumour >1cm in size.
- ECOG performance status 0, 1 or 2.
- Estimated life expectancy of at least 12 weeks.
- Age >18 years.
- Capable of giving written informed consent.
- Has not has pancreatitis within the previous 3 months.
- 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.
Who cannot join
- Acute pancreatitis in the last 3 months.
- Subject with multiple cysts
- Subjects for whom EUS-FNA or surgery are contraindicated
- Known allergy to fluorescein dye
- 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.
- Any psychiatric disorder making reliable informed consent impossible.
- Pregnancy or breast-feeding.
- ECOG performance status 3 or 4
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Addenbrookes Hospital
Cambridge
Royal Free Hospital
London
University College London Hospitals
London
Freeman Hospital
Newcastle
About this study
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.
Read the 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.
- Conditions
- Pancreatic Cyst, Serous Cystadenoma, Intraductal Papillary Mucinous Neoplasm, Cystadenoma, Mucinous
- Being tested
- AQ-Flex 19 probe (Mauna Kea Technologies, Paris)
- Medical subject headings
- Pancreatic Cyst, Cystadenoma, Serous, Cystadenoma, Mucinous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQ-Flex 19 probe (Mauna Kea Technologies, Paris)Device
Needle-based Confocal Laser Endomicroscopy (nCLE)
| Study group | Role | What they receive |
|---|---|---|
| EUS guided nCLE | Experimental | 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. Receives: Device: AQ-Flex 19 probe (Mauna Kea Technologies, Paris) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Assess the diagnostic accuracy of the Cellvizio nCLE system for diagnosing cystic lesions of the pancreas, compared to standard diagnostic modalities
Measured: 3 years
Secondary outcomes (3)
Adverse events
Record the number of participants with an adverse event due to EUS-nCLE
Measured: 3 years
Interpretation criteria
Develop and validate interpretation criteria for nCLE in the pancreas
Measured: 3 years
Assess margins
Assess the diagnostic accuracy of nCLE in defining the margins and extent of pancreatic tumours intraoperatively
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startJul 2014
- Primary completionOct 2016
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CystStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Steve Pereira, PhD FRCP, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523170
- Sponsor's protocol ID
- 13/0572
- Acronym
- CONCYST
- Status last verified
- Sep 2019
- First submitted
- 22 Jun 2015
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Keane MG, Wehnert N, Perez-Machado M, Fusai GK, Thorburn D, Oppong KW, Carroll N, Metz AJ, Pereira SP. A prospective trial of CONfocal endomicroscopy in CYSTic lesions of the pancreas: CONCYST-01. Endosc Int Open. 2019 Sep;7(9):E1117-E1122. doi: 10.1055/a-0957-2976. Epub 2019 Aug 29.
PubMed 31475228
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II MULTICENTRE Trial of Needle Based Laser Confocal Endomicroscopy of Cystic and Solid Tumours of the Pancreas
- ClinicalTrials.gov ID
- NCT02523170
- Acronym / sponsor ID
- CONCYST / 13/0572
- Conditions
- Pancreatic Cyst, Serous Cystadenoma, Intraductal Papillary Mucinous Neoplasm, Cystadenoma, Mucinous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- Jul 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS guided nCLE | Experimental | Device: AQ-Flex 19 probe (Mauna Kea Technologies, Paris)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A diagnosis of a pancreatic cystic tumour based on multidisciplinary review of imaging for which EUS-FNA is indicated.
- Pancreatic cystic tumour >1cm in size.
- ECOG performance status 0, 1 or 2.
- Estimated life expectancy of at least 12 weeks.
- Age >18 years.
Key exclusion criteria (8 listed)
- Acute pancreatitis in the last 3 months.
- Subject with multiple cysts
- Subjects for whom EUS-FNA or surgery are contraindicated
- Known allergy to fluorescein dye
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AQ-Flex 19 probe (Mauna Kea Technologies, Paris)Needle-based Confocal Laser Endomicroscopy (nCLE) | Device | EUS guided nCLE |
Primary outcome
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 secondary outcomes
Adverse events
Time frame: 3 years
Interpretation criteria
Time frame: 3 years
Assess margins
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Background: PubMed 31475228Keane MG, Wehnert N, Perez-Machado M, Fusai GK, Thorburn D, Oppong KW, Carroll N, Metz AJ, Pereira SP. A prospective trial of CONfocal endomicroscopy in CYSTic lesions of the pancreas: CONCYST-01. Endosc Int Open. 2019 Sep;7(9):E1117-E1122. doi: 10.1055/a-0957-2976. Epub 2019 Aug 29.
- PublicationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Pereira, PhD FRCP principal investigator
University College, London
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AQ-Flex 19 probe (Mauna Kea Technologies, Paris) in people with Pancreatic Cyst and Serous Cystadenoma, run by University College, London at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02523170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.