Multiple Endocrine Neoplasia Type 1, Pancreatic Neuroendocrine Tumor
Conditions
Keywords
Multiple endocrine neoplasia type 1, Pancreatic neuroendocrine tumor, Endoscopic ultrasonography-guided fine-needle injection, Ablation
Brief summary
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.
Interventions
PROCEDUREEUS-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.
Sponsors
Guangxi Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of blood glucose level | 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 | 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 | 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 | Every 6 months up to 24 months | Complete ablation on the CE-CT or CE-EUS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of EUS-FNI | At the time of procedure | The success rate of EUS-FNI |
| Safety of EUS-FNI | Within 1 month after treatment | The occurrence of adverse events |
Countries
China
Contacts
Primary ContactShanyu Qin, MD,Ph.D
Backup ContactHaixing Jiang, MD,Ph.D
Outcome results
None listed