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2014-03
2016-04
2018-04
50
NCT02121366
Guangxi Medical University
Guangxi Medical University
INTERVENTIONAL
EUS-guided Ethanol Ablation of an Insulinoma
The present study aims to evaluate the feasibility, safety and efficacy of EUS-guided ethanol ablation of an insulinoma.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-03-26 | N/A | 2014-04-22 |
2014-04-22 | N/A | 2014-04-23 |
2014-04-23 | N/A | 2014-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| Safety of EUS-guided ethanol ablation | Number of subjects with post-procedure adverse events | 1 to 12 month |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Technical feasibility | Technical success was defined as ethanol is injected and lavaged into target tissue. | during the procedure of treatment |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
