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EUS-guided Ethanol Ablation of an Insulinoma (EUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02121366
Recruitment Status : Unknown
Verified April 2014 by Shanyu Qin, Guangxi Medical University.
Recruitment status was:  Active, not recruiting
First Posted : April 23, 2014
Last Update Posted : April 23, 2014
Information provided by (Responsible Party):
Shanyu Qin, Guangxi Medical University

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

Condition or disease Intervention/treatment Phase
Insulinoma Procedure: EUS-guided ethanol ablation Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Ultrasound (EUS)-Guided Ethanol Ablation of an Insulinoma - A Multi-center Prospective Cohort Study
Study Start Date : March 2014
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Insulinoma
Patients with Insulinomas will received EUS-guided ethanol ablation therapy
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.

Primary Outcome Measures :
  1. Efficacy of EUS-guided ethanol ablation [ Time Frame: 1 to 12 month ]
    Volumes of insulinomas before and after treatment, which are measured by cross-sectional imaging test (CT or MRS).

  2. Safety of EUS-guided ethanol ablation [ Time Frame: 1 to 12 month ]
    Number of subjects with post-procedure adverse events

Secondary Outcome Measures :
  1. Technical feasibility [ Time Frame: during the procedure of treatment ]
    Technical success was defined as ethanol is injected and lavaged into target tissue.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02121366

China, Guangxi
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Sponsors and Collaborators
Guangxi Medical University
Study Chair: Shanyu Qin, MD. Ph.D. First Affiliated Hospital of Guangxi Medical University

Additional Information:
Responsible Party: Shanyu Qin, First Affiliated Hospital of Guangxi Medical University, Guangxi Medical University Identifier: NCT02121366     History of Changes
Other Study ID Numbers: EUS0511
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014

Keywords provided by Shanyu Qin, Guangxi Medical University:
Endoscopic Ultrasound-Guided Fine Needle Aspiration
Ablation Techniques

Additional relevant MeSH terms:
Adenoma, Islet Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs