EUS-guided Ethanol Ablation of an Insulinoma

Guangxi Medical University

Status: Unknown

Conditions: Insulinoma

Treatments: Procedure: EUS-guided ethanol ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT02121366

EUS0511

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Insulinoma

Experimental group

Description:

Patients with Insulinomas will received EUS-guided ethanol ablation therapy

Treatment:

Procedure: EUS-guided ethanol ablation