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.

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.)

Abbreviations: CEA, carcinoembryonic antigen, IPMN, intraductal papillary mucinous neoplasm, MCN, mucinous cystadenoma