EUS-guided ethanol versus saline solution lavage for pancreatic cysts

a randomized, double-blind study

John DeWitt, Kathleen McGreevy, C. Schmidt, William R. Brugge

Research output: Contribution to journalArticle

146 Citations (Scopus)

Abstract

Background: Surgery for pancreatic cysts is associated with significant morbidity. A pilot study previously demonstrated the safety of EUS-guided ethanol lavage of pancreatic cysts. Objective: To determine whether EUS-guided ethanol lavage would decrease pancreatic cyst size more than saline solution lavage. Design: Prospective, multicenter, randomized trial. Setting: Two tertiary referral hospitals in the United States. Patients: Patients referred for EUS with a 1- to 5-cm unilocular pancreatic cyst were randomized to blinded ethanol or saline solution lavage. Three months later, the cyst diameter was remeasured by EUS, and a second unblinded ethanol lavage was performed. Interventions: EUS-guided pancreatic cyst lavage. Main Outcome Measurements: Cyst ablation based on size changes from follow-up EUS, CT, and histology of resected specimens. Results: Of 58 patients randomized, 16 were excluded and 42 underwent initial ethanol (n = 25) or saline solution (n = 17) lavage. Ethanol lavage resulted in a greater mean percentage of decrease in cyst surface area (-42.9; 95% CI, -58.4 to -27.4) compared with saline solution alone (-11.4; 95% CI, -25.0 to 2.2; P = .009). Nineteen (76.0%) of 25 and 14 (82.3%) of 17 patients randomized to ethanol and saline solution, respectively, underwent a second ethanol lavage. A follow-up CT scan demonstrated resolution in 12 (33.3%) of 36 cysts. Histology of 4 resected cysts demonstrated epithelial ablation ranging from 0% (saline solution alone) to 50% to 100% (1 or 2 ethanol lavages). Complication rates were similar in all groups. Limitation: Short-term follow-up. Conclusions: EUS-guided ethanol lavage results in a greater decrease in pancreatic cyst size compared with saline solution lavage with a similar safety profile. Overall CT-defined complete pancreatic cyst ablation was 33.3%. (This study is registered at ClinicalTrials.gov, identifier NCT00233038.).

Original languageEnglish
Pages (from-to)710-723
Number of pages14
JournalGastrointestinal Endoscopy
Volume70
Issue number4
DOIs
StatePublished - Oct 2009

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Pancreatic Cyst
Therapeutic Irrigation
Double-Blind Method
Sodium Chloride
Ethanol
Cysts
Histology
Safety
Tertiary Care Centers
Multicenter Studies

ASJC Scopus subject areas

  • Gastroenterology
  • Radiology Nuclear Medicine and imaging

Cite this

EUS-guided ethanol versus saline solution lavage for pancreatic cysts : a randomized, double-blind study. / DeWitt, John; McGreevy, Kathleen; Schmidt, C.; Brugge, William R.

In: Gastrointestinal Endoscopy, Vol. 70, No. 4, 10.2009, p. 710-723.

Research output: Contribution to journalArticle

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abstract = "Background: Surgery for pancreatic cysts is associated with significant morbidity. A pilot study previously demonstrated the safety of EUS-guided ethanol lavage of pancreatic cysts. Objective: To determine whether EUS-guided ethanol lavage would decrease pancreatic cyst size more than saline solution lavage. Design: Prospective, multicenter, randomized trial. Setting: Two tertiary referral hospitals in the United States. Patients: Patients referred for EUS with a 1- to 5-cm unilocular pancreatic cyst were randomized to blinded ethanol or saline solution lavage. Three months later, the cyst diameter was remeasured by EUS, and a second unblinded ethanol lavage was performed. Interventions: EUS-guided pancreatic cyst lavage. Main Outcome Measurements: Cyst ablation based on size changes from follow-up EUS, CT, and histology of resected specimens. Results: Of 58 patients randomized, 16 were excluded and 42 underwent initial ethanol (n = 25) or saline solution (n = 17) lavage. Ethanol lavage resulted in a greater mean percentage of decrease in cyst surface area (-42.9; 95{\%} CI, -58.4 to -27.4) compared with saline solution alone (-11.4; 95{\%} CI, -25.0 to 2.2; P = .009). Nineteen (76.0{\%}) of 25 and 14 (82.3{\%}) of 17 patients randomized to ethanol and saline solution, respectively, underwent a second ethanol lavage. A follow-up CT scan demonstrated resolution in 12 (33.3{\%}) of 36 cysts. Histology of 4 resected cysts demonstrated epithelial ablation ranging from 0{\%} (saline solution alone) to 50{\%} to 100{\%} (1 or 2 ethanol lavages). Complication rates were similar in all groups. Limitation: Short-term follow-up. Conclusions: EUS-guided ethanol lavage results in a greater decrease in pancreatic cyst size compared with saline solution lavage with a similar safety profile. Overall CT-defined complete pancreatic cyst ablation was 33.3{\%}. (This study is registered at ClinicalTrials.gov, identifier NCT00233038.).",
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N2 - Background: Surgery for pancreatic cysts is associated with significant morbidity. A pilot study previously demonstrated the safety of EUS-guided ethanol lavage of pancreatic cysts. Objective: To determine whether EUS-guided ethanol lavage would decrease pancreatic cyst size more than saline solution lavage. Design: Prospective, multicenter, randomized trial. Setting: Two tertiary referral hospitals in the United States. Patients: Patients referred for EUS with a 1- to 5-cm unilocular pancreatic cyst were randomized to blinded ethanol or saline solution lavage. Three months later, the cyst diameter was remeasured by EUS, and a second unblinded ethanol lavage was performed. Interventions: EUS-guided pancreatic cyst lavage. Main Outcome Measurements: Cyst ablation based on size changes from follow-up EUS, CT, and histology of resected specimens. Results: Of 58 patients randomized, 16 were excluded and 42 underwent initial ethanol (n = 25) or saline solution (n = 17) lavage. Ethanol lavage resulted in a greater mean percentage of decrease in cyst surface area (-42.9; 95% CI, -58.4 to -27.4) compared with saline solution alone (-11.4; 95% CI, -25.0 to 2.2; P = .009). Nineteen (76.0%) of 25 and 14 (82.3%) of 17 patients randomized to ethanol and saline solution, respectively, underwent a second ethanol lavage. A follow-up CT scan demonstrated resolution in 12 (33.3%) of 36 cysts. Histology of 4 resected cysts demonstrated epithelial ablation ranging from 0% (saline solution alone) to 50% to 100% (1 or 2 ethanol lavages). Complication rates were similar in all groups. Limitation: Short-term follow-up. Conclusions: EUS-guided ethanol lavage results in a greater decrease in pancreatic cyst size compared with saline solution lavage with a similar safety profile. Overall CT-defined complete pancreatic cyst ablation was 33.3%. (This study is registered at ClinicalTrials.gov, identifier NCT00233038.).

AB - Background: Surgery for pancreatic cysts is associated with significant morbidity. A pilot study previously demonstrated the safety of EUS-guided ethanol lavage of pancreatic cysts. Objective: To determine whether EUS-guided ethanol lavage would decrease pancreatic cyst size more than saline solution lavage. Design: Prospective, multicenter, randomized trial. Setting: Two tertiary referral hospitals in the United States. Patients: Patients referred for EUS with a 1- to 5-cm unilocular pancreatic cyst were randomized to blinded ethanol or saline solution lavage. Three months later, the cyst diameter was remeasured by EUS, and a second unblinded ethanol lavage was performed. Interventions: EUS-guided pancreatic cyst lavage. Main Outcome Measurements: Cyst ablation based on size changes from follow-up EUS, CT, and histology of resected specimens. Results: Of 58 patients randomized, 16 were excluded and 42 underwent initial ethanol (n = 25) or saline solution (n = 17) lavage. Ethanol lavage resulted in a greater mean percentage of decrease in cyst surface area (-42.9; 95% CI, -58.4 to -27.4) compared with saline solution alone (-11.4; 95% CI, -25.0 to 2.2; P = .009). Nineteen (76.0%) of 25 and 14 (82.3%) of 17 patients randomized to ethanol and saline solution, respectively, underwent a second ethanol lavage. A follow-up CT scan demonstrated resolution in 12 (33.3%) of 36 cysts. Histology of 4 resected cysts demonstrated epithelial ablation ranging from 0% (saline solution alone) to 50% to 100% (1 or 2 ethanol lavages). Complication rates were similar in all groups. Limitation: Short-term follow-up. Conclusions: EUS-guided ethanol lavage results in a greater decrease in pancreatic cyst size compared with saline solution lavage with a similar safety profile. Overall CT-defined complete pancreatic cyst ablation was 33.3%. (This study is registered at ClinicalTrials.gov, identifier NCT00233038.).

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