Clinical trial NCT01057355: Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms
Official title: Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Neoplasms, Cystic, Mucinous, and Serous
Pancreatic Neoplasms
Ultrasonography, Interventional
Keywords: Intraductal papillary mucinous neoplasm
Mucinous cystic neoplasm
Endoscopic ultrasound
Endoscopic retrograde cholangiopancreatography
Pancreatic cyst
Pancreas cyst
Alcohol
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of adverse events requiring treatment or hospitalization
timeFrame: 3 days, 30 days
measure: Decrease in volume of the pancreatic cyst by cross-sectional imaging studies (CT or MR) performed before and after treatment
timeFrame: 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Mark Topazian, M.D.
role: PRINCIPAL_INVESTIGATOR
References: