EUS-guided Ethanol Ablation of an Insulinoma

Guangxi Medical University50 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Insulinoma

Interventions

EUS-guided ethanol ablationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Outcomes

Primary Outcomes

Efficacy of EUS-guided ethanol ablation

Volumes of insulinomas before and after treatment, which are measured by cross-sectional imaging test (CT or MRS).

Time frame: 1 to 12 month

Safety of EUS-guided ethanol ablation

Number of subjects with post-procedure adverse events

Time frame: 1 to 12 month

Secondary Outcomes

Technical feasibility

Technical success was defined as ethanol is injected and lavaged into target tissue.

Time frame: during the procedure of treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.