Is alcohol required for effective pancreatic cyst ablation? The prospective randomized CHARM trial pilot study
Matthew T Moyer, Charles E Dye, Setareh Sharzehi, Brooke Ancrile, Abraham Mathew, Thomas J McGarrity, Niraj Gusani, Nelson Yee, Joyce Wong, John Levenick, Brandy Dougherty-Hamod, Bradley Mathers, Matthew T Moyer, Charles E Dye, Setareh Sharzehi, Brooke Ancrile, Abraham Mathew, Thomas J McGarrity, Niraj Gusani, Nelson Yee, Joyce Wong, John Levenick, Brandy Dougherty-Hamod, Bradley Mathers
Abstract
Background and study aims: In this study, we aim to determine the safety and feasibility of an alcohol-free approach to pancreatic cyst ablation using a chemotherapeutic ablation cocktail.
Patients and methods: In this prospective, randomized, double-blinded pilot study, 10 patients with known mucinous type pancreatic cysts underwent endoscopic ultrasound (EUS)-guided fine needle aspiration and then lavage with either 80 % ethanol or normal saline. Both groups were then treated with a cocktail of paclitaxel and gemcitabine. Primary outcomes were reduction in cyst volume and rates of complications.
Results: At 6 months, patients randomized to the alcohol arm had an 89 % average volume reduction, with a 91 % reduction noted in the alcohol-free arm. Complete ablation was achieved in 67 % of patients in the alcohol-free arm at both 6 and 12 months, whereas the alcohol group recorded complete ablation rates of 50 % and 75 % at 6 and 12 months, respectively. One patient in the alcohol arm developed acute pancreatitis (20 %) with no adverse events in the alcohol-free arm.
Conclusions: This study revealed similar ablation rates between the alcohol ablation group and the alcohol-free arm and demonstrates the safety and feasibility of an alcohol-free ablation protocol. This pilot study suggests that alcohol may not be required for effective cyst ablation.
Conflict of interest statement
Competing interests: Abraham Mathew: Consultant for Boston Scientific since 2013. Matthew T. Moyer: Consultant for Boston Scientific since 2012.
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References
- Ryan D P, Hong T S, Bardeesy N. Pancreatic adenocarcinoma. N Engl J Med. 2014;371:1039–1049.
- de Jong K, Nio C Y, Hermans J J. et al.High prevalence of pancreatic cysts detected by screening magnetic resonance imaging examinations. Clin Gastroenterol Hepatol. 2010;8:806–811.
- Kiely J M, Nakeeb A, Komorowski R A. et al.Cystic pancreatic neoplasms: enucleate or resect? J Gastrointest Surg. 2003;7:890–897.
- Allen P J, D’Angelica M, Gonen M. et al.A selective approach to the resection of cystic lesions of the pancreas: results from 539 consecutive patients. Ann Surg. 2006;244:572–582.
- Goh B K, Tan Y M, Cheow P C. et al.Cystic lesions of the pancreas: an appraisal of an aggressive resectional policy adopted at a single institution during 15 years. Am J Surg. 2006;192:148–154.
- Oh H C, Brugge W R. EUS-guided pancreatic cyst ablation: a critical review (with video) Gastrointest Endosc. 2013;77:526–533.
- DeWitt J, McGreevy K, Schmidt C M. et al.EUS-guided ethanol versus saline solution lavage for pancreatic cysts: a randomized, double-blind study. Gastrointest Endosc. 2009;70:710–723.
- Oh H C, Seo D W, Lee T Y. et al.New treatment for cystic tumors of the pancreas: EUS-guided ethanol lavage with paclitaxel injection. Gastrointest Endosc. 2008;67:636–642.
- DeWitt J M, Al-Haddad M, Sherman S. et al.Alterations in cyst fluid genetics following endoscopic ultrasound-guided pancreatic cyst ablation with ethanol and paclitaxel. Endoscopy. 2014;46:457–464.
- Gardner T. Best of ACG 2012. Gastroenterology & Endoscopy News December. 2012:20–21.
- Venook A P, Egorin M J, Rosner G L. et al.Phase I and pharmacokinetic trial of gemcitabine in patients with hepatic or renal dysfunction: Cancer and Leukemia Group B 9565. J Clin Oncol. 2000;18:2780–2787.
- Kiani A, Kohne C H, Franz T. et al.Pharmacokinetics of gemcitabine in a patient with end-stage renal disease: effective clearance of its main metabolite by standard hemodialysis treatment. Cancer Chemother Pharmacol. 2003;51:266–270.
- Von Hoff D D, Ervin T, Arena F P. et al.Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013;369:1691–1703.
- Tanaka M, Fernandez-del Castillo C, Adsay V. et al.International consensus guidelines 2012 for the management of IPMN and MCN of the pancreas. Pancreatology. 2012;12:183–197.
- Gan S I, Thompson C C, Lauwers G Y. et al.Ethanol lavage of pancreatic cystic lesions: initial pilot study. Gastrointest Endosc. 2005;61:746–752.
- Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRB’s-Improving Human Subject Protection. Jan, 2009.
Source: PubMed