EUS-guided Ethanol Ablation of an Insulinoma (EUS)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Endoscopic Ultrasound (EUS)-Guided Ethanol Ablation of an Insulinoma - A Multi-center Prospective Cohort Study|
- Efficacy of EUS-guided ethanol ablation [ Time Frame: 1 to 12 month ] [ Designated as safety issue: Yes ]Volumes of insulinomas before and after treatment, which are measured by cross-sectional imaging test (CT or MRS).
- Safety of EUS-guided ethanol ablation [ Time Frame: 1 to 12 month ] [ Designated as safety issue: Yes ]Number of subjects with post-procedure adverse events
- Technical feasibility [ Time Frame: during the procedure of treatment ] [ Designated as safety issue: Yes ]Technical success was defined as ethanol is injected and lavaged into target tissue.
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Patients with Insulinomas will received EUS-guided ethanol ablation therapy
Procedure: EUS-guided ethanol ablation
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02121366
|First Affiliated Hospital of Guangxi Medical University|
|Nanning, Guangxi, China, 530021|
|Study Chair:||Shanyu Qin, MD. Ph.D.||First Affiliated Hospital of Guangxi Medical University|