Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms
18 Years
N/A
Both
Neoplasms, Cystic, Mucinous, and Serous, Pancreatic Neoplasms, Ultrasonography, Interventional
Trial Information
Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Occurrence of adverse events requiring treatment or hospitalization
Outcome Time Frame:
3 days, 30 days
Safety Issue:
Yes
Principal Investigator
Mark Topazian, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Institutional Review Board
Study ID:
009-004705
NCT ID:
NCT01057355
Start Date:
January 2010
Completion Date:
January 2015
Related Keywords:
- Neoplasms, Cystic, Mucinous, and Serous
- Pancreatic Neoplasms
- Ultrasonography, Interventional
- Intraductal papillary mucinous neoplasm
- Mucinous cystic neoplasm
- Endoscopic ultrasound
- Endoscopic retrograde cholangiopancreatography
- Pancreatic cyst
- Pancreas cyst
- Alcohol
- Neoplasms
- Pancreatic Neoplasms
- Neoplasms, Cystic, Mucinous, and Serous
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
