EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors

Guangxi Medical University

Status: Enrolling

Conditions: Pancreatic Neuroendocrine Tumor; Multiple Endocrine Neoplasia Type 1

Treatments: Procedure: EUS-guided fine-needle injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05554744

2022-K034-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

MEN1-1-related pNETs

Experimental group

Description:

The patients with MEN1-1-related pNETs will undergo EUS-FNI with ethanol or lauromacrogol

Treatment:

Procedure: EUS-guided fine-needle injection