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

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

Detailed Description
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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

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

Conditions
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Efficacy, Safety, Feasibility

Intervention / Treatment
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* Procedure: EUS-guided ethanol-lipiodol mixture ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EUS-guided ethanol-lipiodol mixture ablation<br>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. | Procedure: EUS-guided ethanol-lipiodol mixture ablation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment response | Final tumor viability will be assessed using contrast enhanced CT, and EUS-guided FNA at 3 years after procedure | more than 3 years after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with post-procedure adverse events | Adverse events were defined as any procedure-related complications during the procedure or within 3 months, including pancreatitis, bleeding, and peripancreatic fluid collection | until 3 months after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuroendocrine tumor, ethanol, endoscopic ultrasonography