NCT01902238

EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Study

EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Feasibility and Long Term Outcome

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The present study evaluate the safety and efficacy of EUS-guided ethanol-lipiodol ablation for the treatment of pancreatic NET

Detailed description

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

Conditions

• Efficacy
• Safety
• Feasibility

Interventions

Type	Name	Description
PROCEDURE	EUS-guided ethanol-lipiodol mixture ablation	By using 3D-volumetric analysis, the optimal volume of ethanol/lipiodol (1:1 mixture) is calculated by computer estimation of areas on each axial image, using EUS software permitting volume calculation. After calculating optimal ethanol volume by 3D volumetric analysis, we advance the needle into the tumor and inject estimated volume of ethanol, typically 1 to 1.5 ml.

Timeline

• Start date: 2013-07-01
• Primary completion: 2017-06-01
• Completion: 2017-08-01
• First posted: 2013-07-18
• Last updated: 2016-12-01

Locations

1 site across 1 country: South Korea