Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

Subjects will undergo EUS and/or ERCP as outpatients. For cysts shown to communicate with the main pancreas duct, a balloon catheter will be placed in the main pancreatic duct via ERCP. The balloon catheter will isolate the cyst from the main pancreatic duct, allowing ethanol injections of the cyst. A pancreatic duct stent will be placed in some patients, requiring repeat endoscopy for removal at another time.

Who is eligible to participate?

Inclusion Criteria: - Presence of a pancreatic cystic lesion, at least 2 cm in maximum diameter - Cyst may communicate, or definitely communicates, with the pancreatic duct (based on prior CT, MR, ERCP, or EUS images) - Treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy - Age at least 18 years - Able to give informed consent - Surgical treatment has been considered and a surgical consultation offered to the patient, OR the subject's cyst does not meet consensus criteria for surgical resection. (Current consensus criteria for resection are one or more of the following: cyst is symptomatic, ≥ 3 cm in diameter, contains a mural nodule, cytology of cyst fluid is positive for malignancy, or main pancreatic duct diameter is > 6 mm.) Exclusion Criteria: - Known or suspected pregnancy, or nursing - History of pancreatitis within 3 months prior to study endoscopy procedures - Cyst has a primarily microcystic architecture on EUS

Last updated:

9/30/2013

NCT ID:

NCT01057355