Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 498-04
NCT ID: NCT02158039
Sponsor Protocol Number: 498-04
About this study
Cystic tumors of the pancreas are fluid-filled growths. They are often treated by surgical removal. A safe and effective non-surgical treatment is desirable. Ethanol (alcohol) injection may treat cysts by killing the lining cells of the cyst, and is an accepted treatment for cysts of other organs. In this study, participants with pancreatic cysts will undergo endoscopic ultrasound (EUS) guided ethanol injection of pancreatic cysts. This is a pilot study to assess safety and efficacy.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility 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.
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Mark Topazian, M.D.
Closed for enrollment