EUS-guided Ethanol Ablation of an Insulinoma

Insulinoma Clinical Trial

— EUS  

Official title:

Endoscopic Ultrasound (EUS)-Guided Ethanol Ablation of an Insulinoma - A Multi-center Prospective Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02121366
• Other study ID #: EUS0511
• Status: Active, not recruiting
• Phase: N/A
• First received: March 26, 2014
• Last updated: April 22, 2014
• Start date: March 2014
• Est. completion date: April 2018

Study information

• Verified date: April 2014
• Source: Guangxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: April 2018
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulinoma

Intervention

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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of EUS-guided ethanol ablation	Volumes of insulinomas before and after treatment, which are measured by cross-sectional imaging test (CT or MRS).	1 to 12 month
Primary	Safety of EUS-guided ethanol ablation	Number of subjects with post-procedure adverse events	1 to 12 month
Secondary	Technical feasibility	Technical success was defined as ethanol is injected and lavaged into target tissue.	during the procedure of treatment

External Links

•   First Affiliated Hospital of Guangxi Medical University