This trial is active, not recruiting.

Condition insulinoma
Treatment eus-guided ethanol ablation
Sponsor Guangxi Medical University
Start date March 2014
End date April 2016
Trial size 50 participants
Trial identifier NCT02121366, EUS0511


The present study aims to evaluate the feasibility, safety and efficacy of EUS-guided ethanol ablation of an insulinoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients with Insulinomas will received EUS-guided ethanol ablation therapy
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.

Primary Outcomes

Efficacy of EUS-guided ethanol ablation
time frame: 1 to 12 month
Safety of EUS-guided ethanol ablation
time frame: 1 to 12 month

Secondary Outcomes

Technical feasibility
time frame: during the procedure of treatment

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: 1. Adults: at least 18 years. 2. Patients with insulinomas which are evaluated by histopathology . 3. patients who have signed a written consent form. Exclusion Criteria: 1. Patients whose condition is not suitable for the endoscopic procedure. 2. Patients who have blood coagulation dysfunction. 3. Patients who have mental disorders. 4. Patients who have mild or severe cardiorespiratory insufficiency. 5. Patients who have hypertension and could not be controlled to safe level. 6. Pregnant and lactating women. 7. Patients whose conditions are not suitable for the present study.

Additional Information

Official title Endoscopic Ultrasound (EUS)-Guided Ethanol Ablation of an Insulinoma - A Multi-center Prospective Cohort Study
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Guangxi Medical University.