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EUS-guided Ethanol Ablation of an Insulinoma (EUS)

Primary Purpose

Insulinoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EUS-guided ethanol ablation
Sponsored by
Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulinoma focused on measuring Endoscopic Ultrasound-Guided Fine Needle Aspiration, Insulinoma, Ethanol, Ablation Techniques

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • First Affiliated Hospital of Guangxi Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Insulinoma

Arm Description

Patients with Insulinomas will received EUS-guided ethanol ablation therapy

Outcomes

Primary Outcome Measures

Efficacy of EUS-guided ethanol ablation
Volumes of insulinomas before and after treatment, which are measured by cross-sectional imaging test (CT or MRS).
Safety of EUS-guided ethanol ablation
Number of subjects with post-procedure adverse events

Secondary Outcome Measures

Technical feasibility
Technical success was defined as ethanol is injected and lavaged into target tissue.

Full Information

First Posted
March 26, 2014
Last Updated
April 22, 2014
Sponsor
Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02121366
Brief Title
EUS-guided Ethanol Ablation of an Insulinoma
Acronym
EUS
Official Title
Endoscopic Ultrasound (EUS)-Guided Ethanol Ablation of an Insulinoma - A Multi-center Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangxi Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulinoma
Keywords
Endoscopic Ultrasound-Guided Fine Needle Aspiration, Insulinoma, Ethanol, Ablation Techniques

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Insulinoma
Arm Type
Experimental
Arm Description
Patients with Insulinomas will received EUS-guided ethanol ablation therapy
Intervention Type
Procedure
Intervention Name(s)
EUS-guided ethanol ablation
Intervention Description
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 Measure Information:
Title
Efficacy of EUS-guided ethanol ablation
Description
Volumes of insulinomas before and after treatment, which are measured by cross-sectional imaging test (CT or MRS).
Time Frame
1 to 12 month
Title
Safety of EUS-guided ethanol ablation
Description
Number of subjects with post-procedure adverse events
Time Frame
1 to 12 month
Secondary Outcome Measure Information:
Title
Technical feasibility
Description
Technical success was defined as ethanol is injected and lavaged into target tissue.
Time Frame
during the procedure of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults: at least 18 years. Patients with insulinomas which are evaluated by histopathology . patients who have signed a written consent form. Exclusion Criteria: Patients whose condition is not suitable for the endoscopic procedure. Patients who have blood coagulation dysfunction. Patients who have mental disorders. Patients who have mild or severe cardiorespiratory insufficiency. Patients who have hypertension and could not be controlled to safe level. Pregnant and lactating women. Patients whose conditions are not suitable for the present study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shanyu Qin, MD. Ph.D.
Organizational Affiliation
First Affiliated Hospital of Guangxi Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.gxmuyfy.cn/gxmufy1/1fy/index/index.asp
Description
First Affiliated Hospital of Guangxi Medical University

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EUS-guided Ethanol Ablation of an Insulinoma

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