Original articleClinical endoscopyEUS-guided ethanol versus saline solution lavage for pancreatic cysts: a randomized, double-blind study
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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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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