NCT05554744

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2015

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

10.5 years

First QC Date

September 19, 2022

Last Update Submit

September 24, 2022

Conditions

Multiple Endocrine Neoplasia Type 1Pancreatic Neuroendocrine Tumor

Keywords

Multiple endocrine neoplasia type 1Pancreatic neuroendocrine tumorEndoscopic ultrasonography-guided fine-needle injectionAblation

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Feasibility of EUS-FNI

    At the time of procedure

  • Safety of EUS-FNI

    Within 1 month after treatment

Study Arms (1)

MEN1-1-related pNETs

EXPERIMENTAL

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

Procedure: EUS-guided fine-needle injection

Interventions

EUS-guided fine-needle injectionPROCEDURE

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.

MEN1-1-related pNETs

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1Adenoma, Islet Cell

Condition Hierarchy (Ancestors)

Multiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePancreatic NeoplasmsDigestive System NeoplasmsDigestive System DiseasesPancreatic Diseases

Study Officials

  • Shanyu Qin, Ph.D

    First Affiliated Hospital of Guangxi Medical University

    STUDY CHAIR

Central Study Contacts

Shanyu Qin, MD,Ph.D

CONTACT

86-771-5353725qsy0511@163.com

Haixing Jiang, MD,Ph.D

CONTACT

86-771-5353725gxjiaghx@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 19, 2022

First Posted

September 26, 2022

Study Start

June 18, 2015

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

September 27, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

Locations

CN(1)