Efficacy, Feasibility, Safety
Conditions
Keywords
neuroendocrine tumor, ethanol, endoscopic ultrasonography
Brief summary
The present study evaluate the safety and efficacy of EUS-guided ethanol-lipiodol ablation for the treatment of pancreatic NET
Detailed description
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
Interventions
PROCEDUREEUS-guided ethanol-lipiodol mixture ablation
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.
Sponsors
Dankook University
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pancreas NET(including insulinoma) \< 2cm in diameter * Poor surgical candidate (involving the head of the pancreas or multifocal NET, advanced comorbidity, age \>75 years of age) * Refuse to surgery
Exclusion criteria
* Younger than 18 years of age * Coagulopathy (INR \>1.5, Platelet \<50,000) * Evidence of active pancreatitis * Inability to safely undergo EUS * Refuse to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment response | more than 3 years after procedure | Final tumor viability will be assessed using contrast enhanced CT, and EUS-guided FNA at 3 years after procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of participants with post-procedure adverse events | until 3 months after procedure | Adverse events were defined as any procedure-related complications during the procedure or within 3 months, including pancreatitis, bleeding, and peripancreatic fluid collection |
Other
| Measure | Time frame | Description |
|---|---|---|
| Technical feasibility | at the time of procedure | Technical success was defined as the ability to access and inject the mixture of ethanol/lipiodol into target tissue. |
Countries
South Korea
Outcome results
None listed