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The present study aims to evaluate the feasibility, safety and efficacy of EUS-FNI for MEN1-related pNETs
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEN1-1-related pNETs | Experimental | The patients with MEN1-1-related pNETs will undergo EUS-FNI with ethanol or lauromacrogol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS-guided fine-needle injection | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shanyu Qin, MD,Ph.D | Contact | 86-771-5353725 | qsy0511@163.com | |
| Haixing Jiang, MD,Ph.D | Contact | 86-771-5353725 | gxjiaghx@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shanyu Qin, Ph.D | First Affiliated Hospital of Guangxi Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | 530021 | China |
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| ID | Term |
|---|---|
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| D007516 | Adenoma, Islet Cell |
| ID | Term |
|---|---|
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| D009378 |
| Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |