InsulinomaEUSNCT02121366
EUS-guided Ethanol Ablation of an Insulinoma
A study testing EUS-guided ethanol ablation in people with Insulinoma, run by Guangxi Medical University at 1 site in China.
Trial summary
The present study aims to evaluate the feasibility, safety and efficacy of EUS-guided ethanol ablation of an insulinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Insulinoma
- What is being tested?
- EUS-guided ethanol ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults: at least 18 years.
- Patients with insulinomas which are evaluated by histopathology .
- patients who have signed a written consent form.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
About this study
Official title: 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.
Read the 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.
- Conditions
- Insulinoma
- Being tested
- EUS-guided ethanol ablation
- Keywords
- Endoscopic Ultrasound-Guided Fine Needle Aspiration, Insulinoma, Ethanol, Ablation Techniques
- Medical subject headings
- Insulinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided ethanol ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Insulinoma | Experimental | Patients with Insulinomas will received EUS-guided ethanol ablation therapy Receives: Procedure: EUS-guided ethanol ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of EUS-guided ethanol ablation
Volumes of insulinomas before and after treatment, which are measured by cross-sectional imaging test (CT or MRS).
Measured: 1 to 12 month
Safety of EUS-guided ethanol ablation
Number of subjects with post-procedure adverse events
Measured: 1 to 12 month
Secondary outcomes (1)
Technical feasibility
Technical success was defined as ethanol is injected and lavaged into target tissue.
Measured: during the procedure of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2016 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsulinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shanyu Qin, Guangxi Medical University
- Investigators
- Shanyu Qin, MD. Ph.D., Study chair, First Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121366
- Sponsor's protocol ID
- EUS0511
- Acronym
- EUS
- Status last verified
- Apr 2014
- First submitted
- 26 Mar 2014
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound (EUS)-Guided Ethanol Ablation of an Insulinoma - A Multi-center Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02121366
- Acronym / sponsor ID
- EUS / EUS0511
- Conditions
- Insulinoma
- Keywords
- Endoscopic Ultrasound-Guided Fine Needle Aspiration, Insulinoma, Ethanol, Ablation Techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulinoma | Experimental | Procedure: EUS-guided ethanol ablationPatients with Insulinomas will received EUS-guided ethanol ablation therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults: at least 18 years.
- Patients with insulinomas which are evaluated by histopathology .
- patients who have signed a written consent form.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-guided ethanol ablationDiagnostic 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. | Procedure or surgery | Insulinoma |
Primary outcome
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).
Safety of EUS-guided ethanol ablation
Time frame: 1 to 12 month
Number of subjects with post-procedure adverse events
1 secondary outcome
Technical feasibility
Time frame: during the procedure of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanyu Qin, MD. Ph.D. study chair
First Affiliated Hospital of Guangxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided ethanol ablation in people with Insulinoma, run by Guangxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of EUS-guided ethanol ablation (time frame: 1 to 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2014.