Pancreatic Cyst Clinical Trial
— CONCYSTOfficial title:
A Phase II MULTICENTRE Trial of Needle Based Laser Confocal Endomicroscopy of Cystic and Solid Tumours of the Pancreas
NCT number | NCT02523170 |
Other study ID # | 13/0572 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2014 |
Est. completion date | April 2018 |
Verified date | September 2019 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 67 |
Est. completion date | April 2018 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Addenbrookes Hospital | Cambridge | |
United Kingdom | Royal Free Hospital | London | |
United Kingdom | University College London Hospitals | London | |
United Kingdom | Freeman Hospital | Newcastle |
Lead Sponsor | Collaborator |
---|---|
University College, London | Cambridge University Hospitals NHS Foundation Trust |
United Kingdom,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Adverse events | Record the number of participants with an adverse event due to EUS-nCLE | 3 years | |
Secondary | Interpretation criteria | Develop and validate interpretation criteria for nCLE in the pancreas | 3 years | |
Secondary | Assess margins | Assess the diagnostic accuracy of nCLE in defining the margins and extent of pancreatic tumours intraoperatively | 3 years |
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