EUS-guided ethanol versus saline solution lavage for pancreatic cysts: a randomized, double-blind study.
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.


METHODS
Prospective, multicenter, randomized trial.


METHODS
Two tertiary referral hospitals in the United States.


METHODS
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.


METHODS
EUS-guided pancreatic cyst lavage.


METHODS
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.


CONCLUSIONS
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%.
DeWitt
John
J
Department of Gastroenterology and Hepatology, Massachusetts General Hospital, Boston, Massachusetts, USA. jodewitt@iupui.edu
McGreevy
Kathleen
K
Schmidt
Christian M
CM
Brugge
William R
WR
D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D019160:Endosonography; D000431:Ethanol / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010181:Pancreatic Cyst / Q000628:therapy*; D011446:Prospective Studies; D012965:Sodium Chloride / Q000008:administration & dosage*; D007507:Therapeutic Irrigation / Q000379:methods*
D000970:Antineoplastic Agents; D000431:Ethanol; D012965:Sodium Chloride