EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors

Sponsor

Guangxi Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05554744

Collaborator

(none)

Enrollment

Location

Arm

125.5

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Endocrine Neoplasia Type 1 Pancreatic Neuroendocrine Tumor	Procedure: EUS-guided fine-needle injection	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 18, 2015

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MEN1-1-related pNETs The patients with MEN1-1-related pNETs will undergo EUS-FNI with ethanol or lauromacrogol	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.

Arm

Intervention/Treatment

Experimental: MEN1-1-related pNETs

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

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with MEN1-1-related pNETs are evaluated by histopathology and genetic testing.
Patients who refuse surgery.
Patients who have given their fully informed consent.

Exclusion Criteria:

Patients who are not suitable for the endoscopic procedure.
Patients who have blood coagulation dysfunction, mental disorders, mild or severe cardiorespiratory.