Multiple Endocrine Neoplasia Type 1NCT05554744
EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors
A study testing EUS-guided fine-needle injection in people with Multiple Endocrine Neoplasia Type 1 and Pancreatic Neuroendocrine Tumor, 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-FNI for MEN1-related pNETs Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multiple Endocrine Neoplasia Type 1, Pancreatic Neuroendocrine Tumor
- What is being tested?
- EUS-guided fine-needle injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 18 Jun 2015to Dec 2025
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with MEN1-1-related pNETs are evaluated by histopathology and genetic testing.
- Patients who refuse surgery.
- Patients who have given their fully informed consent.
Who cannot join
- Patients who are not suitable for the endoscopic procedure.
- Patients who have blood coagulation dysfunction, mental disorders, mild or severe cardiorespiratory.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Shanyu Qin, MD,Ph.D, 86-771-5356725, qsy0511@163.com
Shanyu Qin, MD,Ph.D
About this study
Official title: Endoscopic Ultrasound-guided Fine-needle Injection for Multiple Endocrine Neoplasia Type 1-related Pancreatic Neuroendocrine Tumors: a Prospective Multicenter Study
The present study aims to evaluate the feasibility, safety and efficacy of EUS-FNI for MEN1-related pNETs
Read the detailed description
The management of multiple endocrine neoplasia type 1 (MEN1-1)-related pancreatic neuroendocrine tumors (pNETs) remains controversial. In general, surgical resection is currently the first-line therapy for MEN1-1-related pNETs. However, the surgical resection of pNETs is conditional for specific patients, and the incidence of postoperative adverse events is still high. Recently, several studies have demonstrated that endoscopic ultrasonography (EUS)-guided fine-needle injection (EUS-FNI) with ethanol or lauromacrogol may provide an alternative to surgical resection of pNETs. Nevertheless, their sample size was relatively small and conclusions were drawn based on short-term results. Therefore, a multicenter prospective study is being performed to further access the efficacy and safety of EUS-FNI for MEN1-1-related pNETs.
- Being tested
- EUS-guided fine-needle injection
- Keywords
- Multiple endocrine neoplasia type 1, Pancreatic neuroendocrine tumor, Endoscopic ultrasonography-guided fine-needle injection, Ablation
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1, Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided fine-needle injectionProcedure or surgery
Diagnostic evaluation for suspected MEN1-1-related pNETs is conducted by cytology or immunohistochemistry and genetic testing. EUS-FNA is performed to obtain samples. After puncturing with the needle, ethanol/ lauromacrogol under the guidance of EUS was injected into the tumor The volume of ethanol/ lauromacrogol is administrated based on the tumor size.
| Study group | Role | What they receive |
|---|---|---|
| MEN1-1-related pNETs | Experimental | The patients with MEN1-1-related pNETs will undergo EUS-FNI with ethanol or lauromacrogol Receives: Procedure: EUS-guided fine-needle injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of blood glucose level
Changes in the lowest blood glucose levels between baseline and last treatment and each study visit
Measured: Within 7 days of the last ablation and every 6 months up to 24 months
Changes of insulin level
hanges in the insulin levels between baseline and last treatment and each study visit
Measured: Within 7 days of the last ablation and every 6 months up to 24 months
Changes of C peptide
Changes in the C peptide levels between baseline and last treatment and each study visit
Measured: Within 7 days of the last ablation and every 6 months up to 24 months
Imaging response
Complete ablation on the CE-CT or CE-EUS
Measured: Every 6 months up to 24 months
Secondary outcomes (2)
Feasibility of EUS-FNI
The success rate of EUS-FNI
Measured: At the time of procedure
Safety of EUS-FNI
The occurrence of adverse events
Measured: Within 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start18 Jun 2015
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Endocrine Neoplasia Type 1Studies 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
- 20 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, Ph.D, Study chair, First Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554744
- Sponsor's protocol ID
- 2022-K034-01
- Status last verified
- Sep 2022
- First submitted
- 19 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-guided Fine-needle Injection for Multiple Endocrine Neoplasia Type 1-related Pancreatic Neuroendocrine Tumors: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT05554744
- Acronym / sponsor ID
- 2022-K034-01
- Keywords
- Multiple endocrine neoplasia type 1, Pancreatic neuroendocrine tumor, Endoscopic ultrasonography-guided fine-needle injection, Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 18 Jun 2015 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Sep 2022 (actual)
- 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-FNI for MEN1-related pNETs
Detailed description
The management of multiple endocrine neoplasia type 1 (MEN1-1)-related pancreatic neuroendocrine tumors (pNETs) remains controversial. In general, surgical resection is currently the first-line therapy for MEN1-1-related pNETs. However, the surgical resection of pNETs is conditional for specific patients, and the incidence of postoperative adverse events is still high. Recently, several studies have demonstrated that endoscopic ultrasonography (EUS)-guided fine-needle injection (EUS-FNI) with ethanol or lauromacrogol may provide an alternative to surgical resection of pNETs. Nevertheless, their sample size was relatively small and conclusions were drawn based on short-term results. Therefore, a multicenter prospective study is being performed to further access the efficacy and safety of EUS-FNI for MEN1-1-related pNETs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEN1-1-related pNETs | Experimental | Procedure: EUS-guided fine-needle injectionThe patients with MEN1-1-related pNETs will undergo EUS-FNI with ethanol or lauromacrogol |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with MEN1-1-related pNETs are evaluated by histopathology and genetic testing.
- Patients who refuse surgery.
- Patients who have given their fully informed consent.
Key exclusion criteria (2 listed)
- Patients who are not suitable for the endoscopic procedure.
- Patients who have blood coagulation dysfunction, mental disorders, mild or severe cardiorespiratory.
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 fine-needle injectionDiagnostic evaluation for suspected MEN1-1-related pNETs is conducted by cytology or immunohistochemistry and genetic testing. EUS-FNA is performed to obtain samples. After puncturing with the needle, ethanol/ lauromacrogol under the guidance of EUS was injected into the tumor The volume of ethanol/ lauromacrogol is administrated based on the tumor size. | Procedure or surgery | MEN1-1-related pNETs |
Primary outcome
Changes of blood glucose level
Time frame: Within 7 days of the last ablation and every 6 months up to 24 months
Changes in the lowest blood glucose levels between baseline and last treatment and each study visit
Changes of insulin level
Time frame: Within 7 days of the last ablation and every 6 months up to 24 months
hanges in the insulin levels between baseline and last treatment and each study visit
Changes of C peptide
Time frame: Within 7 days of the last ablation and every 6 months up to 24 months
Changes in the C peptide levels between baseline and last treatment and each study visit
Imaging response
Time frame: Every 6 months up to 24 months
Complete ablation on the CE-CT or CE-EUS
2 secondary outcomes
Feasibility of EUS-FNI
Time frame: At the time of procedure
Safety of EUS-FNI
Time frame: Within 1 month after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: Yes
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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, 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 fine-needle injection in people with Multiple Endocrine Neoplasia Type 1 and Pancreatic Neuroendocrine Tumor, 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 2 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 27 Sep 2022. 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?
Contact Shanyu Qin, MD,Ph.D (86-771-5353725, qsy0511@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of blood glucose level (time frame: Within 7 days of the last ablation and every 6 months up to 24 months). The study lists 4 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 27 Sep 2022.