Clinical Trial: Endoscopic Ultrasound (EUS) Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: EUS Guided Ethanol With Paclitaxel Ablation for Pancreatic Mucinous Cystic Neoplasm

Brief Summary:

Pancreatic cysts are becoming diagnosed more frequently due to the increased use and sensitivity of imaging. A subset of these cysts are pre-cancerous, therefore suggested treatment is surgery for removal. However, surgery involves significant risks and emerging opinion suggests that not all cysts need to be surgically removed. An alternative therapy would be ideal, in particular for those where surgical risk outweighs the benefits of resection. Ethanol and paclitaxel ablation of pancreatic cysts may be a viable alternative to surgical resection.

Our hypothesis is that ethanol with paclitaxel ablation is a safe and effective method for treatment in those with per-cancerous, mucinous pancreatic cysts.


Detailed Summary:
Sponsor: Lawson Health Research Institute

Current Primary Outcome:

  • Efficacy: Cyst Resolution [ Time Frame: 6 months ]
    Proportion of patients without cysts at 6 months
  • Efficacy: Degree of Ablation [ Time Frame: 6 months ]
    Degree of cyst epithelial ablation in those undergoing resection


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety [ Time Frame: 30 day ]
    Safety of ethanol/paclitaxel ablation
  • Efficacy: Change of tumor markers [ Time Frame: 12 month ]
    Change of CEA level in those with persistent/recurrent cyst
  • Efficacy: Cyst Resolution [ Time Frame: 12 month ]
    Proportion of patients without cysts at 12 months
  • Efficacy: Cyst Resolution [ Time Frame: 18 months ]
    Proportion of patients without cysts at 18 months
  • Efficacy: Cyst Resolution [ Time Frame: 24 months ]
    Proportion of patients with no cysts at 24 months


Original Secondary Outcome: Same as current

Information By: Lawson Health Research Institute

Dates:
Date Received: February 1, 2012
Date Started: September 2012
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016