The CHARM Trial: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts

NCT01475331 Phase 2 COMPLETED Results posted

The purpose of this study is to evaluate the efficacy of a chemotherapeutic cocktail with or without prior ethanol lavage for ablation of premalignant pancreatic cysts using endoscopic ultrasound-guided fine needle injection (EUS-FNI) for agent delivery.

Details

Lead sponsor	Milton S. Hershey Medical Center
Phase	Phase 2
Status	COMPLETED
Enrolment	46
Start date	2011-11
Completion	2017-01

Conditions

• Mucinous Pancreatic Cysts

Interventions

• Ethanol
• Normal Saline
• Chemotherapy

Primary outcomes

• Number of Participants With the Changing in Cyst Volume — 6, and 12 months post procedure
  The primary outcome of interest will be change in cyst size, as measured on initial, 6, and 12 month CT/MRI, or as determined necessary to evaluate cyst resolution. Cyst size was calculated by measuring x and y diameters and calculating cyst volume using the formula:4/3xpxr3 where r is the average of the cyst radius as measured on the initial, 6-month, and 12-month magnetic resonance imaging or computed tomography. Response was defined according to the same volume percentage reductions as described in previous trials where: complete response is a =\>95% reduction in cyst volume, partial response is a 94%-75% reduction, and anon-response is \<75% reduction in volume.11 The overall ablation rates in both arms were also compared with historical controls to assess the efficacy of the chemotherapeutic cocktail.

Countries

United States