EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors

Pancreatic Neuroendocrine Tumor Clinical Trial

Official title:

Endoscopic Ultrasound-guided Fine-needle Injection for Multiple Endocrine Neoplasia Type 1-related Pancreatic Neuroendocrine Tumors: a Prospective Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05554744
• Other study ID #: 2022-K034-01
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2015
• Est. completion date: December 2025

Study information

• Verified date: September 2022
• Source: Guangxi Medical University
• Contact: Shanyu Qin, MD,Ph.D
• Phone: 86-771-5353725
• Email: qsy0511[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study aims to evaluate the feasibility, safety and efficacy of EUS-FNI for MEN1-related pNETs

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endocrine Gland Neoplasms
• Multiple Endocrine Neoplasia
• Multiple Endocrine Neoplasia Type 1
• Neoplasms
• Neuroendocrine Tumors
• Pancreatic Neuroendocrine Tumor

Intervention

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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of blood glucose level	Changes in the lowest blood glucose levels between baseline and last treatment and each study visit	Within 7 days of the last ablation and every 6 months up to 24 months
Primary	Changes of insulin level	hanges in the insulin levels between baseline and last treatment and each study visit	Within 7 days of the last ablation and every 6 months up to 24 months
Primary	Changes of C peptide	Changes in the C peptide levels between baseline and last treatment and each study visit	Within 7 days of the last ablation and every 6 months up to 24 months
Primary	Imaging response	Complete ablation on the CE-CT or CE-EUS	Every 6 months up to 24 months
Secondary	Feasibility of EUS-FNI	The success rate of EUS-FNI	At the time of procedure
Secondary	Safety of EUS-FNI	The occurrence of adverse events	Within 1 month after treatment