EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors

Not Applicable

Recruiting

• Conditions: Pancreatic Neuroendocrine Tumor; Multiple Endocrine Neoplasia Type 1
• Interventions: Procedure: EUS-guided fine-needle injection

• Registration Number: NCT05554744
• Lead Sponsor: Guangxi Medical University

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.

Study Timeline

• Study Start: 2015-06-18
• Status Verified: 2022-09
• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-21
• Last Update Submitted: 2022-09-24
• Study First Posted: 2022-09-26
• Last Update Posted: 2022-09-27
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MEN1-1-related pNETs	EUS-guided fine-needle injection	The patients with MEN1-1-related pNETs will undergo EUS-FNI with ethanol or lauromacrogol

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China