Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

EUS is performed via the mouth under sedation. After a needle is placed into the pancreas cyst under EUS guidance, an ethanol solution is placed into the cyst via the needle. The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution. After this treatment usual clinical follow-up is obtained including assessments of the cyst by CT or MRI scans. If a cyst of significant size persists additional EUS-guided ethanol injections of the cyst will be offered.

Who is eligible to participate?

Inclusion Criteria: - Presence of a pancreatic cystic lesion, > 1.5 cm in maximum diameter - Treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy - Age > or = 18 years - Able to give informed consent - Surgical treatment has been considered, and a surgical consultation offered to the patient, but the subject's cyst does not meet consensus criteria for surgical resection, or the subject is deemed a poor operative candidate, or ethanol ablation would allow a subtotal rather than total pancreatectomy, or the subject has decided not to undergo surgical treatment. Exclusion Criteria: - Known or suspected pregnancy, or nursing - History of pancreatitis within past 3 months - Main pancreatic duct is dilated to > 4mm in body or tail - Cyst is known to communicate with the pancreatic duct - Cyst has a primarily microcystic architecture on EUS - Cyst is immediately adjacent to the main pancreatic duct on EUS - Cyst has a connection to the main pancreatic duct seen during EUS - During initial cyst aspiration, more fluid is recovered than expected (suggesting communication to the main pancreatic duct) - Pancreatic cytology has demonstrated cancer

Last updated:

6/4/2014

NCT ID:

NCT02158039

IRB Number:

498-04