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.

Original languageEnglish (US)
Pages (from-to)1295-1303
Number of pages9
JournalGastroenterology
Volume153
Issue number5
DOIs
StatePublished - Nov 2017

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Pancreatic Cyst
Alcohols
Safety
Paclitaxel
Cysts
Therapeutic Irrigation
Ethanol
gemcitabine
Control Groups
Randomized Controlled Trials

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

Cite this

@article{8ebc59dfee6f477e9de601c49b5ff0b4,
title = "The Safety and Efficacy of an Alcohol-Free Pancreatic Cyst Ablation Protocol",
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.",
author = "Moyer, {Matthew T.} and Setareh Sharzehi and Abraham Mathew and Levenick, {John M.} and Headlee, {Brandy D.} and Blandford, {Jonathan T.} and Heisey, {Heather D.} and Birkholz, {James H.} and Ancrile, {Brooke B.} and Maranki, {Jennifer L.} and Gusani, {Niraj J.} and McGarrity, {Thomas J.} and Dye, {Charles E.}",
year = "2017",
month = "11",
doi = "10.1053/j.gastro.2017.08.009",
language = "English (US)",
volume = "153",
pages = "1295--1303",
journal = "Gastroenterology",
issn = "0016-5085",
publisher = "W.B. Saunders Ltd",
number = "5",

}

The Safety and Efficacy of an Alcohol-Free Pancreatic Cyst Ablation Protocol. / Moyer, Matthew T.; Sharzehi, Setareh; Mathew, Abraham; Levenick, John M.; Headlee, Brandy D.; Blandford, Jonathan T.; Heisey, Heather D.; Birkholz, James H.; Ancrile, Brooke B.; Maranki, Jennifer L.; Gusani, Niraj J.; McGarrity, Thomas J.; Dye, Charles E.

In: Gastroenterology, Vol. 153, No. 5, 11.2017, p. 1295-1303.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The Safety and Efficacy of an Alcohol-Free Pancreatic Cyst Ablation Protocol

AU - Moyer, Matthew T.

AU - Sharzehi, Setareh

AU - Mathew, Abraham

AU - Levenick, John M.

AU - Headlee, Brandy D.

AU - Blandford, Jonathan T.

AU - Heisey, Heather D.

AU - Birkholz, James H.

AU - Ancrile, Brooke B.

AU - Maranki, Jennifer L.

AU - Gusani, Niraj J.

AU - McGarrity, Thomas J.

AU - Dye, Charles E.

PY - 2017/11

Y1 - 2017/11

N2 - 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.

AB - 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.

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U2 - 10.1053/j.gastro.2017.08.009

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