EUS-guided Ethanol Ablation of an Insulinoma

Study Overview
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Brief Summary
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The present study aims to evaluate the feasibility, safety and efficacy of EUS-guided ethanol ablation of an insulinoma.

Detailed Description
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As the major insulinomas are functioning islet cell tumors, surgical resection is currently first-line therapy for or treatment of insulinomas. However, the surgical resection of pancreatic neoplasm is conditional for specific patients and may be associated with substantial life-threatening complications. Several studies declared that endoscopic ultrasound (EUS)-guided lavage may offer an alternative to surgical resection of insulinomas. Nevertheless, their sample sizes were small and conclusions were built based on short-term outcomes. In addition, the amount of ethanol administrated for different types of insulinomas were inconsistent among those studies. The present study aims to evaluate the safety, feasibility and efficacy of EUS-guided ethanol ablation therapy of insulinomas. We will use cytopathology and immunohistochemistry in combination with EUS-FNA for diagnosis of insulinoma. After EUS-guided ethanol ablation therapy, the safety and efficacy will be assessed at the baseline and different time points during follow-up by physicians blinded to the treatment or control status.

Official Title
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Endoscopic Ultrasound (EUS)-Guided Ethanol Ablation of an Insulinoma - A Multi-center Prospective Cohort Study

Conditions
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Insulinoma

Intervention / Treatment
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* Procedure: EUS-guided ethanol ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults: at least 18 years. Patients with insulinomas which are evaluated by histopathology . patients who have signed a written consent form. Exclusion Criteria: Patients whose condition is not suitable for the endoscopic procedure. Patients who have blood coagulation dysfunction. Patients who have mental disorders. Patients who have mild or severe cardiorespiratory insufficiency. Patients who have hypertension and could not be controlled to safe level. Pregnant and lactating women. Patients whose conditions are not suitable for the present study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Insulinoma<br>Patients with Insulinomas will received EUS-guided ethanol ablation therapy | Procedure: EUS-guided ethanol ablation<br>* Diagnostic evaluation for suspected insulinoma is performed by cytology or immunohistochemistry. EUS-FNA is performed to obtain samples. After puncturing with the needle, ethanol under the guidance of EUS was injected into the lesion. The amount of ethanol is administrated according to the size of lesion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of EUS-guided ethanol ablation | Volumes of insulinomas before and after treatment, which are measured by cross-sectional imaging test (CT or MRS). | 1 to 12 month | 
| Safety of EUS-guided ethanol ablation | Number of subjects with post-procedure adverse events | 1 to 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical feasibility | Technical success was defined as ethanol is injected and lavaged into target tissue. | during the procedure of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulinoma, Endoscopic Ultrasound-Guided Fine Needle Aspiration, Ethanol, Ablation Techniques