EUS-FNI for Nonfunctional Pancreatic Neuroendocrine Tumors

Study Overview
=================
Brief Summary
-----------------
The current study aims to access the feasibility, safety, and efficacy of EUS-FNI for nonfunctional pNETs

Detailed Description
-----------------
The management of nonfunctional pancreatic neuroendocrine tumors (NF-pNETs) remains controversial. In general, surgical resection is the standard treatment for NF-pNETs. However, the incidence of postoperative adverse events of surgical resection is relatively high. Recently, several studies have revealed that endoscopic ultrasonography (EUS)-guided fine-needle injection (EUS-FNI) with ethanol or lauromacrogol may offer an effective treatment for pNETs. Therefore, a multicenter prospective study is being conducted to further identify the efficacy and safety of EUS-FNI for NF-pNETs.

Official Title
-----------------
Endoscopic Ultrasound-guided Fine-needle Injection for Nonfunctional Pancreatic Neuroendocrine Tumors: a Prospective Multicenter Study

Conditions
-----------------
Nonfunctional Pancreatic Neuroendocrine Tumor, Pancreatic Neuroendocrine Tumor, Endoscopic Ultrasound

Intervention / Treatment
-----------------
* Procedure: EUS-guided ethanol ablation
* Procedure: EUS-guided lauromacrogol ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with NF-pNETs are evaluated by cytology or immunohistochemistry. Patients who refuse surgery or observation. Patients who have given their fully informed consent. Exclusion Criteria: Patients who are not suitable for EUS-FNI. Patients who have poor conditions including blood coagulation dysfunction, mental disorders, and mild or severe cardiorespiratory.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nonfunctional pancreatic neuroendocrine tumors<br>The patients with NF-pNETs will undergo EUS-guided ethanol or lauromacrogol ablation | Procedure: EUS-guided ethanol ablation<br>* After puncturing with the needle, 95% ethanol under the guidance of EUS was injected into the tumor. The injection volume of ethanol was estimated according to the following principles: (1) The injection volume was not larger than the tumor spherical volume. (2) Injection volume was reduced when the tumor was adjacent to the pancreatic duct or vessel. (3) Injection volume for the lesions with repeated EUS-FNI was reduced.<br>Procedure: EUS-guided lauromacrogol ablation<br>* After puncturing with the needle, lauromacrogol under the guidance of EUS was injected into the tumor. The injection volume of lauromacrogol was estimated according to the following principles: (1) The injection volume was not larger than the tumor spherical volume. (2) Injection volume was reduced when the tumor was adjacent to the pancreatic duct or vessel. (3) Injection volume for the lesions with repeated EUS-FNI was reduced.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of complete ablation | The rate of complete ablation on the CE-CT or CE-EUS | At 24 months after treatment | 
| The Chang The change of tumor size | The change of tumor size on the CE-CT or EUS | From baseline to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | The incidence of adverse events （such as abdominal pain, hematoma formation, ulcer at the puncture site, acute pancreatitis, pancreatic necrosis, and pancreatic duct stricture） | Within 3 month after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nonfunctional Pancreatic Neuroendocrine Tumor, Endoscopic ultrasonography-guided fine-needle injection, Ablation, Endoscopic ultrasonography