EUS-FNI treatment for pancreatic tumors in MEN1 patients
Endoscopic Ultrasound-guided Fine-needle Injection for Multiple Endocrine Neoplasia Type 1-related Pancreatic Neuroendocrine Tumors: a Prospective Multicenter Study
This study is testing if a new treatment called EUS-FNI can safely help people with pancreatic tumors related to MEN1 instead of having surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Guangxi Medical University Academic / other |
| Locations | 1 site (Nanning, Guangxi) |
| Trial ID | NCT05554744 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility, safety, and efficacy of endoscopic ultrasonography-guided fine-needle injection (EUS-FNI) as a treatment for pancreatic neuroendocrine tumors (pNETs) associated with multiple endocrine neoplasia type 1 (MEN1). Surgical resection is typically the first-line therapy, but this approach may not be suitable for all patients due to high postoperative risks. The study aims to provide a multicenter prospective analysis to determine if EUS-FNI can serve as a viable alternative to surgery. Participants will be monitored for outcomes related to the effectiveness and safety of this intervention.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with MEN1-related pNETs who refuse surgical intervention and meet specific eligibility criteria.
Not a fit: Patients unsuitable for endoscopic procedures or those with blood coagulation dysfunction or severe cardiorespiratory issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a less invasive treatment option for patients with MEN1-related pNETs, reducing the need for surgery and associated complications.
How similar studies have performed: Previous studies have shown promising results for EUS-FNI in small sample sizes, but this study aims to provide more comprehensive data on its efficacy and safety.
Eligibility criteria
Show full 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.
Where this trial is running
Nanning, Guangxi
- First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (Recruiting)
Study contacts
- Study coordinator: Shanyu Qin, MD,Ph.D
- Email: qsy0511@163.com
- Phone: 86-771-5353725
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.