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CHARM: Ethanol-free EUS-guided chemoablation safe, effective
ORLANDO — An ethanol-free protocol for pancreatic cyst ablation followed by a combined paclitaxel and gemcitabine regimen for pancreatic neoplasia was effective and led to significant reductions in adverse events, according to research presented at the World Congress of Gastroenterology at ACG 2017.
“This is important because significantly improving the risk profile of this procedure, while preserving its efficacy, increases the attractiveness of this therapeutic option for patients with precancerous-type pancreatic cysts,” Matthew T. Moyer, MD, MS, of Penn State University Milton S. Hershey Medical Center, said during his presentation.
While endoscopic ultrasound (EUS)-guided chemoablation of mucinous-type pancreatic cysts with ethanol and paclitaxel is a well-known effective intervention, the risk for pancreatitis associated with ethanol use remains a concern and the significance of ethanol in the ablation process remains unclear, according to study background.
The CHARM trial included 39 patients who underwent EUS-guided fine needle aspiration for mucinous-type pancreatic cysts randomly assigned to lavage with 80% ethanol or normal saline. All patients received a paclitaxel plus gemcitabine regimen following ablation.
Primary outcome measures included the rates of complete cyst ablation at 6 months and 1 year, and major and minor adverse events that occurred within 30 days of ablation.
At 1 year, the rate of complete ablation was 67% among patients in the ethanol-free arm vs. 61% among those in the ethanol arm. The overall rate of complete ablation was 64%.
There were no patients in the ethanol-free arm who experienced adverse events. Conversely, serious adverse events occurred in 6% and minor complications in 22% of patients in the ethanol arm.
“There is a significant reduction in adverse events associated with ablation when this ethanol-free protocol was used,” Moyer said. “Improving the safety of this technique should increase the attractiveness of EUS-guided chemoablation of mucinous pancreatic cysts in appropriately-selected patients.” – Jennifer Southall
Reference: Moyer MT, et al. Abstract 45. Presented at: World Congress of Gastroenterology at American College of Gastroenterology Annual Scientific Meeting; Oct. 13-18, 2017; Orlando, FL.
Disclosure : Moyer reports being a consultant for Boston Scientific Corp.