Clinical Trial: Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms
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 Summary: 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.
Sponsor: Mayo Clinic
Current Primary Outcome:
- Occurrence of adverse events requiring treatment or hospitalization [ Time Frame: 3 days, 30 days ]
- Decrease in volume of the pancreatic cyst by cross-sectional imaging studies (CT or MR) performed before and after treatment [ Time Frame: 6 months, 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Mayo Clinic
Dates:
Date Received: January 26, 2010
Date Started: January 2010
Date Completion:
Last Updated: September 17, 2014
Last Verified: September 2014
