Neoplasms, Cystic, Mucinous, and Serous, Pancreatic Neoplasms, Ultrasonography, Interventional
Conditions
Keywords
Intraductal papillary mucinous neoplasm, Mucinous cystic neoplasm, Endoscopic ultrasound, Endoscopic retrograde cholangiopancreatography, Pancreatic cyst, Pancreas cyst, Alcohol
Brief summary
Pancreatic cysts are common, and some pancreas cysts have malignant potential. Usual treatment of these cysts is either observation or surgical removal of part or all of the pancreas. Minimally invasive treatment via endoscopy has been described, using endoscopic ultrasound (EUS) guided ethanol injections. Such studies exclude cysts that communicate with the main pancreatic duct, to avoid burning the main pancreatic duct with ethanol. In this study, pancreas cysts communicating with the main pancreas duct are treated with ethanol via endoscopic retrograde cholangiopancreatography (ERCP) and/or EUS.
Detailed description
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.
Interventions
PROCEDUREEUS and/or ERCP with ethanol injections of pancreatic cyst
Lavage of cyst with 80% ethanol
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events requiring treatment or hospitalization | 3 days, 30 days |
| Decrease in volume of the pancreatic cyst by cross-sectional imaging studies (CT or MR) performed before and after treatment | 6 months, 12 months |
Outcome results
None listed