Clinical Trial: EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Study
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Feasibility and Long Term Outcome
Brief Summary: The present study evaluate the safety and efficacy of EUS-guided ethanol-lipiodol ablation for the treatment of pancreatic NET
Detailed Summary: Pancreatic neuroendocrine tumor, including insulinoma, increasingly are being encountered in clinical practice. Management of pancreatic NET is challenging because most are asymptomatic but may have malignant potential, and surgical resection of pancreatic neoplasm is associated with substantial morbidity of 20%-40% and a mortality rate of 2%. Management strategy needs to be individualized, applying a risk-benefit analysis to each patient. Recently, pancreatic tissue ablation by EUS-guided injection of ethanol or other chemotherapeutic agents can be performed safely, with few procedure-related complications. Levy et al. demonstrated that EUS-guided ethanol ablation for insulinoma was both safe and feasible, and symptomatic improvement was achieved in 8 of 8 patients (100%). However, previous study have included only a small number of patients and evaluated only short-term outcomes. In addition, lipiodol permits the drug to concentrate in the tumor. To obtain an embolic effect and prevent washout of the ethanol, ethanol/lipiodol mixture is administered into the tumor. The present study evaluate the safety and efficacy of EUS-guided ethanol-lipiodol ablation for the treatment of pancreatic NET
Sponsor: Asan Medical Center
Current Primary Outcome: Number of participants with treatment response [ Time Frame: more than 3 years after procedure ]
Original Primary Outcome: Number of participants with treatment response [ Time Frame: until 1 year after procedure ]
Current Secondary Outcome: The number of participants with post-procedure adverse events [ Time Frame: until 3 months after procedure ]
Original Secondary Outcome: The number of pariticipants with post-procedure adverse events [ Time Frame: until 3 months after procedure ]
Information By: Asan Medical Center
Dates:
Date Received: July 15, 2013
Date Started: July 2013
Date Completion: August 2017
Last Updated: November 29, 2016
Last Verified: November 2016