EUS-FNI for Nonfunctional Pancreatic Neuroendocrine Tumors
Endoscopic Ultrasound-guided Fine-needle Injection for Nonfunctional Pancreatic Neuroendocrine Tumors: a Prospective Multicenter Study
1 other identifier
interventional
20
1 country
1
Brief Summary
The current study aims to access the feasibility, safety, and efficacy of EUS-FNI for nonfunctional pNETs
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
Longer than P75 for not_applicable
1 active site
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
September 28, 2018
CompletedFirst Submitted
Initial submission to the registry
September 25, 2022
CompletedFirst Posted
Study publicly available on registry
October 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedOctober 4, 2022
September 1, 2022
7.3 years
September 25, 2022
September 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The rate of complete ablation
The rate of complete ablation on the CE-CT or CE-EUS
At 24 months after treatment
The Chang The change of tumor size
The change of tumor size on the CE-CT or EUS
From baseline to 24 months
Secondary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Within 3 month after treatment
Study Arms (1)
Nonfunctional pancreatic neuroendocrine tumors
EXPERIMENTALThe patients with NF-pNETs will undergo EUS-guided ethanol or lauromacrogol ablation
Interventions
After puncturing with the needle, 95% ethanol under the guidance of EUS was injected into the tumor. The injection volume of ethanol was estimated according to the following principles: (1) The injection volume was not larger than the tumor spherical volume. (2) Injection volume was reduced when the tumor was adjacent to the pancreatic duct or vessel. (3) Injection volume for the lesions with repeated EUS-FNI was reduced.
After puncturing with the needle, lauromacrogol under the guidance of EUS was injected into the tumor. The injection volume of lauromacrogol was estimated according to the following principles: (1) The injection volume was not larger than the tumor spherical volume. (2) Injection volume was reduced when the tumor was adjacent to the pancreatic duct or vessel. (3) Injection volume for the lesions with repeated EUS-FNI was reduced.
Eligibility Criteria
You may qualify if:
- Patients with NF-pNETs are evaluated by cytology or immunohistochemistry.
- Patients who refuse surgery or observation.
- Patients who have given their fully informed consent.
You may not qualify if:
- Patients who are not suitable for EUS-FNI.
- Patients who have poor conditions including blood coagulation dysfunction, mental disorders, and 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shanyu Qin, MD,Ph.D
First Affiliated Hospital of Guangxi Medical University
Central Study Contacts
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 25, 2022
First Posted
October 4, 2022
Study Start
September 28, 2018
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
October 4, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share