CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts: a prospective, randomized, double-blind, multi-center clinical trial
The overall objectives are to verify the findings of the CHARM I pilot study in a multi-center trial as requested by national investigators in this field and improve on the limitations identified in that trail. We hypothesize that pancreatic cyst infusion with a specifically designed chemotherapeutic cocktail following normal saline lavage will result in cyst ablation rates that do not significantly differ from those achieved by a single chemotherapeutic infusion following ethanol lavage which is the conventional approach at this time. Furthermore, we hypothesize that the removal of alcohol from the ablation process will decrease adverse event rates associated with pancreatic cyst ablation. In order to test this hypothesis and confirm the findings of CHARM I, we propose a multicenter, prospective, randomized double-blind controlled study to evaluate pancreatic cystic tumor ablation with or without ethanol lavage.
We expect that administering a specifically designed chemotherapeutic cocktail without prior ethanol lavage will result in an equivalent rate of cyst resolution with fewer complications when compared with lavage using alcohol. The results of this study will provide important information about the most efficient and safest method for treating premalignant pancreatic cysts, an important step for treating these lesions with a minimally invasive technique and preventing their progression to pancreatic cancer.
Standard alternative treatment options for this patient group (if not taking part in this study) would be ongoing periodic radiographic surveillance with MR or CT imaging waiting for signs of malignancy to develop or to consider surgical resection (an option with significant rates of morbidity and mortality as described later in the background section of this document).