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| Name | Class |
|---|---|
| Dankook University | OTHER |
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The present study evaluate the safety and efficacy of EUS-guided ethanol-lipiodol ablation for the treatment of pancreatic NET
Pancreatic neuroendocrine tumor, including insulinoma, increasingly are being encountered in clinical practice. Management of pancreatic NET is challenging because most are asymptomatic but may have malignant potential, and surgical resection of pancreatic neoplasm is associated with substantial morbidity of 20%-40% and a mortality rate of 2%. Management strategy needs to be individualized, applying a risk-benefit analysis to each patient. Recently, pancreatic tissue ablation by EUS-guided injection of ethanol or other chemotherapeutic agents can be performed safely, with few procedure-related complications. Levy et al. demonstrated that EUS-guided ethanol ablation for insulinoma was both safe and feasible, and symptomatic improvement was achieved in 8 of 8 patients (100%). However, previous study have included only a small number of patients and evaluated only short-term outcomes. In addition, lipiodol permits the drug to concentrate in the tumor. To obtain an embolic effect and prevent washout of the ethanol, ethanol/lipiodol mixture is administered into the tumor. The present study evaluate the safety and efficacy of EUS-guided ethanol-lipiodol ablation for the treatment of pancreatic NET
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUS-guided ethanol-lipiodol mixture ablation | Experimental | By using 3D-volumetric analysis, the optimal volume of ethanol is calculated by computer estimation of areas on each axial image, using EUS software permitting volume calculation. After calculating optimal ethanol volume by 3D volumetric analysis, we advance the needle into the tumor and inject estimated volume of ethanol/lipiodol (1:1 mixture), typically 1 to 1.5 ml. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS-guided ethanol-lipiodol mixture ablation | Procedure | By using 3D-volumetric analysis, the optimal volume of ethanol/lipiodol (1:1 mixture) is calculated by computer estimation of areas on each axial image, using EUS software permitting volume calculation. After calculating optimal ethanol volume by 3D volumetric analysis, we advance the needle into the tumor and inject estimated volume of ethanol, typically 1 to 1.5 ml. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment response | Final tumor viability will be assessed using contrast enhanced CT, and EUS-guided FNA at 3 years after procedure | more than 3 years after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants with post-procedure adverse events | Adverse events were defined as any procedure-related complications during the procedure or within 3 months, including pancreatitis, bleeding, and peripancreatic fluid collection | until 3 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Technical feasibility | Technical success was defined as the ability to access and inject the mixture of ethanol/lipiodol into target tissue. | at the time of procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Do Hyun Park, MD, PhD | Asan Medical Center, Seoul, Korea, Republic of | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D009380 | Neoplasms, Nerve Tissue |