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2015-06-18
2025-12
2025-12
20
NCT05554744
Guangxi Medical University
Guangxi Medical University
INTERVENTIONAL
EUS-FNI for MEN1-related Pancreatic Neuroendocrine Tumors
The present study aims to evaluate the feasibility, safety and efficacy of EUS-FNI for MEN1-related pNETs
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-09-19 | N/A | 2022-09-24 |
2022-09-21 | N/A | 2022-09-27 |
2022-09-26 | N/A | 2022-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
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
|
| Primary Outcome Measures | 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 | 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 |
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 |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
