Skip to main content
Clinical Trials/NCT02523170
NCT02523170CompletedNot Applicable

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

University College, London4 sites in 1 country67 target enrollmentStarted: July 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
67
Locations
4
Primary Endpoint
Diagnostic accuracy

Study Overview

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.

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

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • 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

Outcomes

Primary Outcomes

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 Outcomes

  • Adverse events(3 years)
  • Interpretation criteria(3 years)
  • Assess margins(3 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

Loading locations...

Similar Trials