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

Not Applicable

• Conditions: Safety; Efficacy; Feasibility
• Interventions: Procedure: EUS-guided ethanol-lipiodol mixture ablation

• Registration Number: NCT01902238
• Lead Sponsor: Asan Medical Center

Brief 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

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-07-15
• Study First Posted: 2013-07-18
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-29
• Last Update Posted: 2016-12-01
• Primary Completion: 2017-06
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Pancreas NET(including insulinoma) < 2cm in diameter
• Poor surgical candidate (involving the head of the pancreas or multifocal NET, advanced comorbidity, age >75 years of age)
• Refuse to surgery

Exclusion Criteria

• Younger than 18 years of age
• Coagulopathy (INR >1.5, Platelet <50,000)
• Evidence of active pancreatitis
• Inability to safely undergo EUS
• Refuse to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EUS-guided ethanol-lipiodol mixture ablation	EUS-guided ethanol-lipiodol mixture ablation	By using 3D-volumetric analysis, the optimal volume of ethanol 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/lipiodol (1:1 mixture), typically 1 to 1.5 ml.

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment response	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

Secondary Outcome Measures

Name	Time	Method
The number of participants with post-procedure adverse events	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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of