EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-18

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Multiple Endocrine Neoplasia Type 1 Pancreatic Neuroendocrine Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MEN1-1-related pNETs

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

Group Type EXPERIMENTAL

EUS-guided fine-needle injection

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No