EUS-guided Ethanol Ablation of an Insulinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Insulinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulinoma

Patients with Insulinomas will received EUS-guided ethanol ablation therapy

Group Type EXPERIMENTAL

EUS-guided ethanol ablation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No