The present study aims to evaluate the feasibility, safety and efficacy of EUS-FNI for MEN1-related pNETs
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITINGChanges of blood glucose level
Changes in the lowest blood glucose levels between baseline and last treatment and each study visit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Every 6 months up to 24 months
Feasibility of EUS-FNI
The success rate of EUS-FNI
Time frame: At the time of procedure
Safety of EUS-FNI
The occurrence of adverse events
Time frame: Within 1 month after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.