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Gastrointest Endosc. 2009 Oct;70(4):710-23. doi: 10.1016/j.gie.2009.03.1173. Epub 2009 Jul 4.

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

Author information

1
Department of Gastroenterology and Hepatology, Massachusetts General Hospital, Boston, Massachusetts, USA. jodewitt@iupui.edu

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%.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00233038.

PMID:
19577745
DOI:
10.1016/j.gie.2009.03.1173
[Indexed for MEDLINE]
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