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Trial Title:
EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors
NCT ID:
NCT05554744
Condition:
Multiple Endocrine Neoplasia Type 1
Pancreatic Neuroendocrine Tumor
Conditions: Official terms:
Neoplasms
Neuroendocrine Tumors
Adenoma, Islet Cell
Endocrine Gland Neoplasms
Multiple Endocrine Neoplasia
Multiple Endocrine Neoplasia Type 1
Conditions: Keywords:
Multiple endocrine neoplasia type 1
Pancreatic neuroendocrine tumor
Endoscopic ultrasonography-guided fine-needle injection
Ablation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
EUS-guided fine-needle injection
Description:
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.
Arm group label:
MEN1-1-related pNETs
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Guangxi Medical University
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Contact:
Last name:
Shanyu Qin, MD,Ph.D
Phone:
86-771-5356725
Email:
qsy0511@163.com
Investigator:
Last name:
Shanyu Qin, MD,Ph.D
Email:
Principal Investigator
Start date:
June 18, 2015
Completion date:
December 2025
Lead sponsor:
Agency:
Guangxi Medical University
Agency class:
Other
Source:
Guangxi Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05554744
