An interventional study of EUS-guided fine-needle injection in Multiple Endocrine Neoplasia Type 1 and Pancreatic Neuroendocrine Tumor, sponsored by Guangxi Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-09-27.
Sponsored by Guangxi Medical University · Not applicable, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Exclusion Criteria:
The patients with MEN1-1-related pNETs will undergo EUS-FNI with ethanol or lauromacrogol
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.
Changes 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
Plan to share: Yes
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Guangxi Medical University