Endoscopic Ultrasound-guided Ethanol Injection of Pancreatic Cystic Neoplasms
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
Site IRB
- Rochester, Minnesota: 498-04
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.
Participation eligibility
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Mark Topazian, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available