EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors

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

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

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Neuroendocrine Tumor; Multiple Endocrine Neoplasia Type 1
• Intervention / Treatment: Procedure: EUS-guided fine-needle injection

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shanyu Qin, MD,Ph.D; Phone Number: 86-771-5353725; Email: qsy0511@163.com
• Study Contact Backup: Name: Haixing Jiang, MD,Ph.D; Phone Number: 86-771-5353725; Email: gxjiaghx@163.com

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Recruiting
      • First Affiliated Hospital of Guangxi Medical University
      • Contact: Shanyu Qin, MD,Ph.D; Phone Number: 86-771-5356725; Email: qsy0511@163.com
      • Principal Investigator: Shanyu Qin, MD,Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Imaging response	Complete ablation on the CE-CT or CE-EUS	Every 6 months up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of EUS-FNI	The success rate of EUS-FNI	At the time of procedure
Safety of EUS-FNI	The occurrence of adverse events	Within 1 month after treatment

Collaborators and Investigators

• Sponsor: Guangxi Medical University
• Investigators: Study Chair: Shanyu Qin, Ph.D, First Affiliated Hospital of Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2015
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 24, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Ablation; Pancreatic neuroendocrine tumor; Endoscopic ultrasonography-guided fine-needle injection; Multiple endocrine neoplasia type 1
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Genetic Diseases, Inborn; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplastic Syndromes, Hereditary; Pancreatic Diseases; Adenoma; Neoplasms, Multiple Primary; Pancreatic Neoplasms; Neoplasms; Neuroendocrine Tumors; Endocrine Gland Neoplasms; Adenoma, Islet Cell; Multiple Endocrine Neoplasia; Multiple Endocrine Neoplasia Type 1
• Other Study ID Numbers: 2022-K034-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No