Fewer adverse events with alcohol-free pancreatic cyst ablation
Last Updated: 2017-08-24
By Will Boggs MD
NEW YORK (Reuters Health) - Alcohol-free pancreatic cyst ablation yields similar complete-ablation rates with fewer adverse events, compared to ablation using alcohol, researchers report in a single-center randomized trial.
"Current guidelines do not recommend endoscopic ultrasound (EUS)-guided ablation as part of standard clinical care, in large part due to its side-effect profile," Dr. Matthew T. Moyer from Penn State Hershey Medical Center, in Pennsylvania, told Reuters Health by email. "By removing alcohol from the equation, a more favorable safety profile for this procedure presents itself, raising a need to reevaluate this approach in appropriately selected patients."
"The use of alcohol to destroy neoplastic lesions of the pancreas is surrounded by controversy," he explained. "It is both of limited value when used alone, due to low efficacy, and its inflammatory nature is proposed to be the likely cause of almost all serious adverse events that have occurred in pancreatic cyst ablation in previous trials."
Dr. Moyer's team randomized 39 patients with mucinous type pancreatic cysts to EUS-guided pancreatic cyst lavage with either 80% ethanol (control) or normal saline (alcohol-free), followed by an infusion of paclitaxel mixed with gemcitabine.
The study was published online, August 9, in Gastroenterology.
At 6 months, average cyst-volume reduction was 78% in the control group and 84% in the alcohol-free group. Complete ablation rates at 12 months did not differ significantly between the control group (61%) and the alcohol-free group (67%).
All of the adverse events occurred in the control (alcohol) group: one serious event (acute pancreatitis) and four minor events (abdominal pain).
The researchers caution that the study was limited to use of only one ablation, which is likely too conservative to achieve high complete-ablation rates, and the amount of chemotherapeutic cocktail was limited by the FDA to 8 mL. Moreover, the single-center study was weakly powered to reveal differences in outcomes with high levels of scientific certainty.
"The fact that the study showed that alcohol is not required for effective pancreatic cyst ablation was exciting," Dr. Moyer said by email. "Further, the significant reduction in adverse events seen in the alcohol-free arm was even more so."
"We are planning on confirming this study with a larger multicenter trial with a larger number of patients," he said.
SOURCE: http://bit.ly/2g91Z6L
Gastroenterology 2017.
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