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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 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. 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.

Sponsor: University College, London

Current 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


Original Primary Outcome: Assess the diagnostic accuracy of the Cellvizio nCLE system for diagnosing cystic lesions of the pancreas, compared to standard diagnostic modalities [ Time Frame: 3 years ]

Current Secondary Outcome:

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


Original Secondary Outcome:

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


Information By: University College, London

Dates:
Date Received: June 22, 2015
Date Started: July 2014
Date Completion: April 2019
Last Updated: May 2, 2017
Last Verified: October 2016