EUS-guided Ethanol Ablation of an Insulinoma (EUS)
|ClinicalTrials.gov Identifier: NCT02121366|
Recruitment Status : Active, not recruiting
First Posted : April 23, 2014
Last Update Posted : April 23, 2014
|Condition or disease||Intervention/treatment|
|Insulinoma||Procedure: EUS-guided ethanol ablation|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Ultrasound (EUS)-Guided Ethanol Ablation of an Insulinoma - A Multi-center Prospective Cohort Study|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2018|
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.
- Efficacy of EUS-guided ethanol ablation [ Time Frame: 1 to 12 month ]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 ]Number of subjects with post-procedure adverse events
- Technical feasibility [ Time Frame: during the procedure of treatment ]Technical success was defined as ethanol is injected and lavaged into target tissue.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|