EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors

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EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors

Study Purpose

The present study aims to evaluate the feasibility, safety and efficacy of EUS-FNI for MEN1-related pNETs

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients with MEN1-1-related pNETs are evaluated by histopathology and genetic testing. 2. Patients who refuse surgery. 3. Patients who have given their fully informed consent.

Exclusion Criteria:

1. Patients who are not suitable for the endoscopic procedure. 2. Patients who have blood coagulation dysfunction, mental disorders, mild or severe cardiorespiratory.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05554744
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Guangxi Medical University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Shanyu Qin, Ph.D
Principal Investigator Affiliation	First Affiliated Hospital of Guangxi Medical University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Endocrine Neoplasia Type 1, Pancreatic Neuroendocrine Tumor

Additional Details

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.

Arms & Interventions

Arms

Experimental: MEN1-1-related pNETs

The patients with MEN1-1-related pNETs will undergo EUS-FNI with ethanol or lauromacrogol

Interventions

Procedure: - EUS-guided fine-needle injection

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.

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