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EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors

Primary Purpose

Multiple Endocrine Neoplasia Type 1, Pancreatic Neuroendocrine Tumor

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EUS-guided fine-needle injection
Sponsored by
Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Endocrine Neoplasia Type 1 focused on measuring Multiple endocrine neoplasia type 1, Pancreatic neuroendocrine tumor, Endoscopic ultrasonography-guided fine-needle injection, Ablation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • First Affiliated Hospital of Guangxi Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MEN1-1-related pNETs

Arm Description

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

Outcomes

Primary Outcome Measures

Changes of blood glucose level
Changes in the lowest blood glucose levels between baseline and last treatment and each study visit
Changes of insulin level
hanges in the insulin levels between baseline and last treatment and each study visit
Changes of C peptide
Changes in the C peptide levels between baseline and last treatment and each study visit
Imaging response
Complete ablation on the CE-CT or CE-EUS

Secondary Outcome Measures

Feasibility of EUS-FNI
The success rate of EUS-FNI
Safety of EUS-FNI
The occurrence of adverse events

Full Information

First Posted
September 19, 2022
Last Updated
September 24, 2022
Sponsor
Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05554744
Brief Title
EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors
Official Title
Endoscopic Ultrasound-guided Fine-needle Injection for Multiple Endocrine Neoplasia Type 1-related Pancreatic Neuroendocrine Tumors: a Prospective Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2015 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Endocrine Neoplasia Type 1, Pancreatic Neuroendocrine Tumor
Keywords
Multiple endocrine neoplasia type 1, Pancreatic neuroendocrine tumor, Endoscopic ultrasonography-guided fine-needle injection, Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MEN1-1-related pNETs
Arm Type
Experimental
Arm Description
The patients with MEN1-1-related pNETs will undergo EUS-FNI with ethanol or lauromacrogol
Intervention Type
Procedure
Intervention Name(s)
EUS-guided fine-needle injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of blood glucose level
Description
Changes in the lowest blood glucose levels between baseline and last treatment and each study visit
Time Frame
Within 7 days of the last ablation and every 6 months up to 24 months
Title
Changes of insulin level
Description
hanges in the insulin levels between baseline and last treatment and each study visit
Time Frame
Within 7 days of the last ablation and every 6 months up to 24 months
Title
Changes of C peptide
Description
Changes in the C peptide levels between baseline and last treatment and each study visit
Time Frame
Within 7 days of the last ablation and every 6 months up to 24 months
Title
Imaging response
Description
Complete ablation on the CE-CT or CE-EUS
Time Frame
Every 6 months up to 24 months
Secondary Outcome Measure Information:
Title
Feasibility of EUS-FNI
Description
The success rate of EUS-FNI
Time Frame
At the time of procedure
Title
Safety of EUS-FNI
Description
The occurrence of adverse events
Time Frame
Within 1 month after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shanyu Qin, MD,Ph.D
Phone
86-771-5353725
Email
qsy0511@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haixing Jiang, MD,Ph.D
Phone
86-771-5353725
Email
gxjiaghx@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shanyu Qin, Ph.D
Organizational Affiliation
First Affiliated Hospital of Guangxi Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shanyu Qin, MD,Ph.D
Phone
86-771-5356725
Email
qsy0511@163.com
First Name & Middle Initial & Last Name & Degree
Shanyu Qin, MD,Ph.D

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors

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