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 ]

Final tumor viability will be assessed using contrast enhanced CT, and EUS-guided FNA at 3 years after procedure


Original Primary Outcome: Number of participants with treatment response [ Time Frame: until 1 year after procedure ]

Treatment responses were assessed by comparing the estimated size at the time of the procedure with the size at the final follow-up evaluation (hypervascular portion).


Current Secondary Outcome: The number of participants with post-procedure adverse events [ Time Frame: until 3 months after procedure ]

Adverse events were defined as any procedure-related complications during the procedure or within 3 months, including pancreatitis, bleeding, and peripancreatic fluid collection


Original Secondary Outcome: The number of pariticipants with post-procedure adverse events [ Time Frame: until 3 months after procedure ]

Adverse events were defined as any procedure-related complications during the procedure or within 3 months, including pancreatitis, bleeding, and peripancreatic fluid collection


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