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The present study aims to evaluate the feasibility, safety and efficacy of EUS-guided ethanol ablation of an insulinoma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulinoma | Experimental | Patients with Insulinomas will received EUS-guided ethanol ablation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS-guided ethanol ablation | Procedure | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Technical feasibility | Technical success was defined as ethanol is injected and lavaged into target tissue. | during the procedure of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shanyu Qin, MD. 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 | Nanning | Guangxi | 530021 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 19, 2015 | |
| Reset | Nov 16, 2015 | |
| Release | Dec 14, 2015 | |
| Unrelease | Yes | |
| Release | Dec 16, 2015 | |
| Reset | Jan 21, 2016 | |
| Release | Aug 9, 2016 | |
| Reset | Sep 30, 2016 | |
| Release | Oct 25, 2016 | |
| Reset | Dec 15, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 19, 2015 | Nov 16, 2015 | |||
| Dec 14, 2015 |
| ID | Term |
|---|---|
| D007340 | Insulinoma |
| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
| Yes |
| Dec 16, 2015 | Jan 21, 2016 |
| Aug 9, 2016 | Sep 30, 2016 |
| Oct 25, 2016 | Dec 15, 2016 |
| D009369 | Neoplasms |
| 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 |