EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors

September 24, 2022 updated by: Shanyu Qin, Guangxi Medical University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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:
        • Principal Investigator:
          • Shanyu Qin, MD,Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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
Within 7 days of the last ablation and every 6 months up to 24 months
Changes of insulin level
Time Frame: 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
Within 7 days of the last ablation and every 6 months up to 24 months
Changes of C peptide
Time Frame: 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
Within 7 days of the last ablation and every 6 months up to 24 months
Imaging response
Time Frame: Every 6 months up to 24 months
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
Time Frame: At the time of procedure
The success rate of EUS-FNI
At the time of procedure
Safety of EUS-FNI
Time Frame: Within 1 month after treatment
The occurrence of adverse events
Within 1 month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangxi Medical University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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