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The current study aims to access the feasibility, safety, and efficacy of EUS-FNI for nonfunctional pNETs
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nonfunctional pancreatic neuroendocrine tumors | Experimental | The patients with NF-pNETs will undergo EUS-guided ethanol or lauromacrogol ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS-guided ethanol ablation | Procedure | 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. |
| 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 |
| 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 |
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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, MD,Ph.D | First Affiliated Hospital of Guangxi Medical University | Principal Investigator |
| 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 |
|---|---|
| C536126 | Non functioning pancreatic endocrine tumor |
| D007516 | Adenoma, Islet Cell |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| EUS-guided lauromacrogol ablation | Procedure | 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. |
|
| D010190 |
| Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |