Nonfunctional Pancreatic Neuroendocrine TumorNCT05566093
EUS-FNI for Nonfunctional Pancreatic Neuroendocrine Tumors
A study testing EUS-guided ethanol ablation and EUS-guided lauromacrogol ablation in people with Nonfunctional Pancreatic Neuroendocrine Tumor and Pancreatic Neuroendocrine Tumor, run by Guangxi Medical University at 1 site in China.
Trial summary
The current study aims to access the feasibility, safety, and efficacy of EUS-FNI for nonfunctional pNETs Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Nonfunctional Pancreatic Neuroendocrine Tumor, Pancreatic Neuroendocrine Tumor, Endoscopic Ultrasound
- What is being tested?
- EUS-guided ethanol ablation and EUS-guided lauromacrogol ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2018to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with NF-pNETs are evaluated by cytology or immunohistochemistry.
- Patients who refuse surgery or observation.
- Patients who have given their fully informed consent.
Who cannot join
- Patients who are not suitable for EUS-FNI.
- Patients who have poor conditions including blood coagulation dysfunction, mental disorders, and mild or severe cardiorespiratory.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Shanyu Qin, MD,Ph.D, 86-771-5356725, qsy0511@163.com
Shanyu Qin, MD,Ph.D
About this study
Official title: Endoscopic Ultrasound-guided Fine-needle Injection for Nonfunctional Pancreatic Neuroendocrine Tumors: a Prospective Multicenter Study
The current study aims to access the feasibility, safety, and efficacy of EUS-FNI for nonfunctional pNETs
Read the detailed description
The management of nonfunctional pancreatic neuroendocrine tumors (NF-pNETs) remains controversial. In general, surgical resection is the standard treatment for NF-pNETs. However, the incidence of postoperative adverse events of surgical resection is relatively high. Recently, several studies have revealed that endoscopic ultrasonography (EUS)-guided fine-needle injection (EUS-FNI) with ethanol or lauromacrogol may offer an effective treatment for pNETs. Therefore, a multicenter prospective study is being conducted to further identify the efficacy and safety of EUS-FNI for NF-pNETs.
- Conditions
- Nonfunctional Pancreatic Neuroendocrine Tumor, Pancreatic Neuroendocrine Tumor, Endoscopic Ultrasound
- Being tested
- EUS-guided ethanol ablation, EUS-guided lauromacrogol ablation
- Keywords
- Nonfunctional Pancreatic Neuroendocrine Tumor, Endoscopic ultrasonography-guided fine-needle injection, Ablation, Endoscopic ultrasonography
- Medical subject headings
- Non functioning pancreatic endocrine tumor, Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided ethanol ablationProcedure or surgery
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.
EUS-guided lauromacrogol ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Nonfunctional pancreatic neuroendocrine tumors | Experimental | The patients with NF-pNETs will undergo EUS-guided ethanol or lauromacrogol ablation Receives: Procedure: EUS-guided ethanol ablation; Procedure: EUS-guided lauromacrogol ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of complete ablation
The rate of complete ablation on the CE-CT or CE-EUS
Measured: At 24 months after treatment
The Chang The change of tumor size
The change of tumor size on the CE-CT or EUS
Measured: From baseline to 24 months
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
The incidence of adverse events （such as abdominal pain, hematoma formation, ulcer at the puncture site, acute pancreatitis, pancreatic necrosis, and pancreatic duct stricture）
Measured: Within 3 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start28 Sep 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonfunctional Pancreatic Neuroendocrine TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shanyu Qin, Guangxi Medical University
- Investigators
- Shanyu Qin, MD,Ph.D, Principal investigator, First Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566093
- Sponsor's protocol ID
- 2022-K039-01
- Status last verified
- Sep 2022
- First submitted
- 25 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-guided Fine-needle Injection for Nonfunctional Pancreatic Neuroendocrine Tumors: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT05566093
- Acronym / sponsor ID
- 2022-K039-01
- Conditions
- Nonfunctional Pancreatic Neuroendocrine Tumor, Pancreatic Neuroendocrine Tumor, Endoscopic Ultrasound
- Keywords
- Nonfunctional Pancreatic Neuroendocrine Tumor, Endoscopic ultrasonography-guided fine-needle injection, Ablation, Endoscopic ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study aims to access the feasibility, safety, and efficacy of EUS-FNI for nonfunctional pNETs
Detailed description
The management of nonfunctional pancreatic neuroendocrine tumors (NF-pNETs) remains controversial. In general, surgical resection is the standard treatment for NF-pNETs. However, the incidence of postoperative adverse events of surgical resection is relatively high. Recently, several studies have revealed that endoscopic ultrasonography (EUS)-guided fine-needle injection (EUS-FNI) with ethanol or lauromacrogol may offer an effective treatment for pNETs. Therefore, a multicenter prospective study is being conducted to further identify the efficacy and safety of EUS-FNI for NF-pNETs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nonfunctional pancreatic neuroendocrine tumors | Experimental | Procedure: EUS-guided ethanol ablation, Procedure: EUS-guided lauromacrogol ablationThe patients with NF-pNETs will undergo EUS-guided ethanol or lauromacrogol ablation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with NF-pNETs are evaluated by cytology or immunohistochemistry.
- Patients who refuse surgery or observation.
- Patients who have given their fully informed consent.
Key exclusion criteria (2 listed)
- Patients who are not suitable for EUS-FNI.
- Patients who have poor conditions including blood coagulation dysfunction, mental disorders, and mild or severe cardiorespiratory.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-guided ethanol ablationAfter 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. | Procedure or surgery | Nonfunctional pancreatic neuroendocrine tumors |
| EUS-guided lauromacrogol ablationAfter 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. | Procedure or surgery | Nonfunctional pancreatic neuroendocrine tumors |
Primary outcome
The rate of complete ablation
Time frame: At 24 months after treatment
The rate of complete ablation on the CE-CT or CE-EUS
The Chang The change of tumor size
Time frame: From baseline to 24 months
The change of tumor size on the CE-CT or EUS
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Within 3 month after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanyu Qin, MD,Ph.D principal investigator
First Affiliated Hospital of Guangxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided ethanol ablation and EUS-guided lauromacrogol ablation in people with Nonfunctional Pancreatic Neuroendocrine Tumor and Pancreatic Neuroendocrine Tumor, run by Guangxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shanyu Qin, MD,Ph.D (86-771-5353725, qsy0511@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of complete ablation (time frame: At 24 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.