EUS-Guided Pancreatic Injection of Cyst (EPIC) Trial
EUS-Guided Pancreatic Injection of Cyst (EPIC) Trial
The purpose of the study is to learn about a new treatment for pancreatic cystic lesions. The
 injection of alcohol into cysts is a common way of treating cysts of the liver, kidney, and
 thyroid. We would like to find out if injection of alcohol would be useful for the treatment
 of pancreatic cystic lesions. The treatment with alcohol will use endoscopy and endoscopic
 ultrasound (procedures that use a scope that is placed through your mouth and into your
 stomach). We hypothesize that more than half of the cysts which are injected with ethanol
 will resolve.
Cystic lesions of the kidney, thyroid, and liver are commonly treated with ethanol injections
 into the cyst cavity. The contact with ethanol results in rapid elimination of epithelial
 cells lining cyst cavities with few complications or pain. The majority of cysts become
 smaller and some are completely eliminated Depending on the type of cyst and tissue, some
 cysts can be completely ablated with ethanol. Although malignant masses arising from the
 pancreas have been safely injected with ethanol, there are no reports of injection of
 pancreatic cystadenomas. The ability to ablate cystadenomas of the pancreas would provide the
 first non-surgical treatment for these pre-malignant lesions of the pancreas.

 Over the past two years we have conducted a pilot study of EUS-guided ethanol lavage of
 pancreatic cysts (2001-P-000358/5). 18 patients have undergone the procedure without evidence
 of pancreatitis, pain, or infection following the procedure. Initially, low concentrations of
 ethanol were used (5%) and over the course of the study, the concentration of the ethanol
 used for lavage has been increased to 60%. Although the patients have not undergone careful
 follow-up evaluations, it appears that at least 4 of the patients have had resolution of the
 cyst.

 This is a prospective, randomized, blinded, controlled trial of ethanol ablation in 50
 patients with a pancreatic cystadenoma. Patients with a pancreatic cyst (1-5cm in diameter)
 capable of safely undergoing endoscopy with conscious sedation will be candidates. Exclusion
 criteria include: coagulopathy (INR>1.5, PTT>100, platelets of< 50k), active infection of the
 cyst or unstable cardio-pulmonary disease (active angina, home O2, or pulmonary edema) will
 be excluded.

 At the time of diagnostic cyst aspiration, the patient will be randomized to either saline
 lavage or ethanol (70%) lavage. During the exam, the cyst will be imaged with ultrasound,
 measured and aspirated. The cyst contents will be evaluated with cytologic evaluation, CEA,
 and amylase. After cyst aspiration, the cyst will be lavaged with either saline or ethanol
 for 5 minutes. At completion of the lavage, the cyst contents will be evacuated. The patient
 will be provided the results of the cyst fluid analysis and may elect to undergo surgical
 resection or additional lavage treatments. At the time of resection, the cyst and surrounding
 pancreas will be resected for histologic analysis. The degree of epithelial ablation will be
 determined with histologic sectioning and the cysts lavaged with ethanol will be compared to
 those cysts lavaged with saline. If the patient chooses not to have a surgical resection, the
 patient may return for a follow-up EUS exam at two additional monthly intervals with cyst
 aspiration and additional ethanol lavage. Those patients receiving saline during the initial
 treatment session will be crossed-over to ethanol.
Inclusion Criteria:

 -  Patients with a pancreatic cyst (1-5cm in diameter)

 -  Capable of safely undergoing endoscopy with conscious sedation

 Exclusion Criteria:

 -  Coagulopathy (INR>1.5, PTT>100, platelets of< 50k)

 -  Active infection of the cyst

 -  Unstable cardio-pulmonary disease (active angina, home O2, or pulmonary edema)