EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors

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-FNI for MEN1-related pNETs

Detailed Description
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The management of multiple endocrine neoplasia type 1 (MEN1-1)-related pancreatic neuroendocrine tumors (pNETs) remains controversial. In general, surgical resection is currently the first-line therapy for MEN1-1-related pNETs. However, the surgical resection of pNETs is conditional for specific patients, and the incidence of postoperative adverse events is still high. Recently, several studies have demonstrated that endoscopic ultrasonography (EUS)-guided fine-needle injection (EUS-FNI) with ethanol or lauromacrogol may provide an alternative to surgical resection of pNETs. Nevertheless, their sample size was relatively small and conclusions were drawn based on short-term results. Therefore, a multicenter prospective study is being performed to further access the efficacy and safety of EUS-FNI for MEN1-1-related pNETs.

Official Title
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Endoscopic Ultrasound-guided Fine-needle Injection for Multiple Endocrine Neoplasia Type 1-related Pancreatic Neuroendocrine Tumors: a Prospective Multicenter Study

Conditions
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Multiple Endocrine Neoplasia Type 1, Pancreatic Neuroendocrine Tumor

Intervention / Treatment
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* Procedure: EUS-guided fine-needle injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with MEN1-1-related pNETs are evaluated by histopathology and genetic testing. Patients who refuse surgery. Patients who have given their fully informed consent. Exclusion Criteria: Patients who are not suitable for the endoscopic procedure. Patients who have blood coagulation dysfunction, mental disorders, mild or severe cardiorespiratory.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: MEN1-1-related pNETs<br>The patients with MEN1-1-related pNETs will undergo EUS-FNI with ethanol or lauromacrogol | Procedure: EUS-guided fine-needle injection<br>* Diagnostic evaluation for suspected MEN1-1-related pNETs is conducted by cytology or immunohistochemistry and genetic testing. EUS-FNA is performed to obtain samples. After puncturing with the needle, ethanol/ lauromacrogol under the guidance of EUS was injected into the tumor The volume of ethanol/ lauromacrogol is administrated based on the tumor size.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of blood glucose level | Changes in the lowest blood glucose levels between baseline and last treatment and each study visit | Within 7 days of the last ablation and every 6 months up to 24 months | 
| Changes of insulin level | hanges in the insulin levels between baseline and last treatment and each study visit | Within 7 days of the last ablation and every 6 months up to 24 months | 
| Changes of C peptide | Changes in the C peptide levels between baseline and last treatment and each study visit | Within 7 days of the last ablation and every 6 months up to 24 months | 
| Imaging response | Complete ablation on the CE-CT or CE-EUS | Every 6 months up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of EUS-FNI | The success rate of EUS-FNI | At the time of procedure | 
| Safety of EUS-FNI | The occurrence of adverse events | Within 1 month after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple endocrine neoplasia type 1, Pancreatic neuroendocrine tumor, Endoscopic ultrasonography-guided fine-needle injection, Ablation