EUS-guided Ethanol Ablation of an Insulinoma (EUS)

April 22, 2014 updated by: Shanyu Qin, Guangxi Medical University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • First Affiliated Hospital of Guangxi Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 to 12 month
Safety of EUS-guided ethanol ablation
Time Frame: 1 to 12 month
Number of subjects with post-procedure adverse events
1 to 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical feasibility
Time Frame: during the procedure of treatment
Technical success was defined as ethanol is injected and lavaged into target tissue.
during the procedure of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangxi Medical University

Investigators

  • Study Chair: Shanyu Qin, MD. Ph.D., First Affiliated Hospital of Guangxi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ANTICIPATED)

April 1, 2016

Study Completion (ANTICIPATED)

April 1, 2018

Study Registration Dates

First Submitted

March 26, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (ESTIMATE)

April 23, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 23, 2014

Last Update Submitted That Met QC Criteria

April 22, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUS0511

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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