EUS-guided ethanol versus saline solution lavage for pancreatic cysts: a randomized, double-blind study - 23/08/11
Reprint requests: John DeWitt, MD, FACP, FASGE, Division of Gastroenterology and Hepatology, Indiana University Medical Center, 550 North University Blvd., UH 4100, Indianapolis, IN 46202.Indianapolis, Indiana, Boston, Massachusetts, USA
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%. (This study is registered at ClinicalTrials.gov, identifier NCT00233038.)
Le texte complet de cet article est disponible en PDF.Abbreviations : CEA, IPMN, MCN
Plan
| 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. |
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| See CME section; p. 748. |
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| If you would like to chat with an author of this article, you may contact him at jodewitt@iupui.edu. |
Vol 70 - N° 4
P. 710-723 - octobre 2009 Retour au numéro
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