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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II MULTICENTRE Trial of Needle Based Laser Confocal Endomicroscopy of Cystic and Solid Tumours of the Pancreas

Conditions
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Pancreatic Cyst, Serous Cystadenoma, Intraductal Papillary Mucinous Neoplasm, Cystadenoma, Mucinous

Intervention / Treatment
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* Device: AQ-Flex 19 probe (Mauna Kea Technologies, Paris)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EUS guided nCLE<br>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)<br>* Needle-based Confocal Laser Endomicroscopy (nCLE)<br>|

What is the study measuring?
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Primary Outcome Measures

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