Original article
Clinical endoscopy
EUS-guided ethanol versus saline solution lavage for pancreatic cysts: a randomized, double-blind study

https://doi.org/10.1016/j.gie.2009.03.1173Get rights and content

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.)

Section snippets

Study population

Eligible patients included those referred to gastroenterology, surgery, or oncology at the 2 participating hospitals with a pancreatic cyst identified by previous cross-sectional imaging. The principal investigator at each site reviewed the medical and imaging records of the patients to assess eligibility. This study was approved by the institutional review boards at both hospitals, and all patients signed informed consent before enrollment (ClinicalTrials.gov identifier NCT00233038 at //clinicaltrials.gov/ct2/show/NCT00233038

Study population

Between October 2004 and January 2007, 80 patients were screened, 22 were excluded, and 58 were randomized to ethanol (n = 29) or saline solution lavage (n = 29). The trial profile is outlined in Figure 1. In the 2 groups, there was no statistically significant difference in patient demographics, CT cyst surface area, or pancreatic cyst location (data not shown; all P values >.50).

In the ethanol and saline solution groups, 4 (13.8%) of 29 and 12 (41.4%) of 29 patients undergoing EUS,

Discussion

In the current study, we found 2 different lines of evidence demonstrating that EUS-guided ethanol injection of pancreatic cysts may lead to varying degrees of cyst epithelial ablation. First, when we used follow-up EUS, 1 ethanol lavage resulted in a greater mean decrease in the cyst size compared with saline solution injection alone (P = .009). Moreover, follow-up CT after 1 or more ethanol lavages also demonstrated cyst resolution in 33% of patients. No cyst elimination was seen in the only

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  • Cited by (0)

    DISCLOSURE: The following author received research support for this study from an American Society for Gastrointestinal Endoscopy Research and Outcomes and Effectiveness grant: W. R. Brugge. The funding source had no role in the study design, collection, analysis, or interpretation of the data or in the decision to submit the manuscript for publication. All other authors disclosed no financial relationships relevant to this publication.

    See CME section; p. 748.

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