Matthew T Moyer1, Setareh Sharzehi2, Abraham Mathew2, John M Levenick2, Brandy D Headlee2, Jonathan T Blandford3, Heather D Heisey4, James H Birkholz5, Brooke B Ancrile2, Jennifer L Maranki2, Niraj J Gusani6, Thomas J McGarrity2, Charles E Dye2. 1. Division of Gastroenterology and Hepatology, Penn State Hershey Medical Center, Hershey, Pennsylvania. Electronic address: mmoyer@pennstatehealth.psu.edu. 2. Division of Gastroenterology and Hepatology, Penn State Hershey Medical Center, Hershey, Pennsylvania. 3. University Endoscopy Center, Penn State Hershey Medical Center, Hershey Pennsylvania. 4. Penn State Hershey Investigational Pharmacy, Penn State Hershey Medical Center, Hershey, Pennsylvania. 5. Department of Radiology, Penn State Hershey Medical Center, Hershey, Pennsylvania. 6. Division of Surgical Oncology, Penn State Hershey Medical Center, Hershey, Pennsylvania.
Abstract
BACKGROUND & AIMS:Endoscopic ultrasound (EUS)-guided chemoablation with ethanol lavage followed by infusion of paclitaxel is effective for the treatment of mucinous pancreatic cysts. However, complications arise in 3%-10% of patients, presumably linked to the inflammatory effects of ethanol. We aimed to determine whether alcohol is required for effective pancreatic cyst ablation, if removing alcohol from the ablation process would improve complication rates, and whether a multi-agent chemotherapeutic cocktail could increase the rate of complete cyst resolution compared with findings reported from previous trials using alcohol followed by paclitaxel alone. METHODS:Between November 2011 and December 2016, we conducted a single-center, prospective, double-blind trial of 39 patients with mucinous-type pancreatic cysts. Patients were randomly assigned to 1 of 2 groups that underwent EUS-guided pancreatic cyst lavage with either 80% ethanol (control) or normal saline (alcohol-free group). Cysts in both groups were then infused with an admixture of paclitaxel and gemcitabine. Primary outcomes were the rates of complete ablation 12 months after the procedure, and rates of serious and minor adverse events within 30 days of the procedure. RESULTS: At 12 months, 67% of patients who underwent alcohol-free EUS-guided cyst chemoablation had complete ablation of cysts compared with 61% of patients in the control group. Serious adverse events occurred in 6% of patients in the control group vs none of the patients in the alcohol-free group. Minor adverse events occurred in 22% of patients in the control group and none of the patients in the alcohol-free group. The overall rate of complete ablation was 64%. CONCLUSIONS: In this prospective, randomized, controlled trial, we found that alcohol is not required for effective EUS-guided pancreatic cyst ablation, and when alcohol is removed from the ablation process, there is a significant reduction in associated adverse events. A multi-agent chemotherapeutic ablation admixture did not appear to significantly improve rates of complete ablation compared with the current standard of alcohol lavage followed by paclitaxel alone. ClinicalTrials.gov ID: NCT01475331.
RCT Entities:
BACKGROUND & AIMS: Endoscopic ultrasound (EUS)-guided chemoablation with ethanol lavage followed by infusion of paclitaxel is effective for the treatment of mucinous pancreatic cysts. However, complications arise in 3%-10% of patients, presumably linked to the inflammatory effects of ethanol. We aimed to determine whether alcohol is required for effective pancreatic cyst ablation, if removing alcohol from the ablation process would improve complication rates, and whether a multi-agent chemotherapeutic cocktail could increase the rate of complete cyst resolution compared with findings reported from previous trials using alcohol followed by paclitaxel alone. METHODS: Between November 2011 and December 2016, we conducted a single-center, prospective, double-blind trial of 39 patients with mucinous-type pancreatic cysts. Patients were randomly assigned to 1 of 2 groups that underwent EUS-guided pancreatic cyst lavage with either 80% ethanol (control) or normal saline (alcohol-free group). Cysts in both groups were then infused with an admixture of paclitaxel and gemcitabine. Primary outcomes were the rates of complete ablation 12 months after the procedure, and rates of serious and minor adverse events within 30 days of the procedure. RESULTS: At 12 months, 67% of patients who underwent alcohol-free EUS-guided cyst chemoablation had complete ablation of cysts compared with 61% of patients in the control group. Serious adverse events occurred in 6% of patients in the control group vs none of the patients in the alcohol-free group. Minor adverse events occurred in 22% of patients in the control group and none of the patients in the alcohol-free group. The overall rate of complete ablation was 64%. CONCLUSIONS: In this prospective, randomized, controlled trial, we found that alcohol is not required for effective EUS-guided pancreatic cyst ablation, and when alcohol is removed from the ablation process, there is a significant reduction in associated adverse events. A multi-agent chemotherapeutic ablation admixture did not appear to significantly improve rates of complete ablation compared with the current standard of alcohol lavage followed by paclitaxel alone. ClinicalTrials.gov ID: NCT01475331.
Authors: Stephen A Firkins; Phil A Hart; Kyle Porter; ChienWei Chiang; Jordan M Cloyd; Mary Dillhoff; Luis F Lara; Andrei Manilchuk; Georgios I Papachristou; Timothy M Pawlik; Allan Tsung; Darwin L Conwell; Somashekar G Krishna Journal: Pancreas Date: 2022-07-19 Impact factor: 3.243
Authors: Andre Bratanic; Dorotea Bozic; Antonio Mestrovic; Dinko Martinovic; Marko Kumric; Tina Ticinovic Kurir; Josko Bozic Journal: World J Gastrointest Oncol Date: 2021-12-15