Back to resultsEUS-FNI for Nonfunctional Pancreatic Neuroendocrine Tumors
Primary Purpose
Nonfunctional Pancreatic Neuroendocrine Tumor, Pancreatic Neuroendocrine Tumor, Endoscopic Ultrasound
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EUS-guided ethanol ablation
EUS-guided lauromacrogol ablation
Sponsored by
About this trial
This is an interventional treatment trial for Nonfunctional Pancreatic Neuroendocrine Tumor focused on measuring Nonfunctional Pancreatic Neuroendocrine Tumor, Endoscopic ultrasonography-guided fine-needle injection, Ablation, Endoscopic ultrasonography
Eligibility Criteria
Inclusion Criteria:
- Patients with NF-pNETs are evaluated by cytology or immunohistochemistry.
- Patients who refuse surgery or observation.
- Patients who have given their fully informed consent.
Exclusion Criteria:
- Patients who are not suitable for EUS-FNI.
- Patients who have poor conditions including blood coagulation dysfunction, mental disorders, and mild or severe cardiorespiratory.
Sites / Locations
- First Affiliated Hospital of Guangxi Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nonfunctional pancreatic neuroendocrine tumors
Arm Description
The patients with NF-pNETs will undergo EUS-guided ethanol or lauromacrogol ablation
Outcomes
Primary Outcome Measures
The rate of complete ablation
The rate of complete ablation on the CE-CT or CE-EUS
The Chang The change of tumor size
The change of tumor size on the CE-CT or EUS
Secondary Outcome Measures
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）
Full Information
NCT ID
NCT05566093
First Posted
September 25, 2022
Last Updated
September 30, 2022
Sponsor
Guangxi Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05566093
Brief Title
EUS-FNI for Nonfunctional Pancreatic Neuroendocrine Tumors
Official Title
Endoscopic Ultrasound-guided Fine-needle Injection for Nonfunctional 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
September 28, 2018 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonfunctional Pancreatic Neuroendocrine Tumor, Pancreatic Neuroendocrine Tumor, Endoscopic Ultrasound
Keywords
Nonfunctional Pancreatic Neuroendocrine Tumor, Endoscopic ultrasonography-guided fine-needle injection, Ablation, Endoscopic ultrasonography
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
Nonfunctional pancreatic neuroendocrine tumors
Arm Type
Experimental
Arm Description
The patients with NF-pNETs will undergo EUS-guided ethanol or lauromacrogol ablation
Intervention Type
Procedure
Intervention Name(s)
EUS-guided ethanol ablation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
EUS-guided lauromacrogol ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
The rate of complete ablation
Description
The rate of complete ablation on the CE-CT or CE-EUS
Time Frame
At 24 months after treatment
Title
The Chang The change of tumor size
Description
The change of tumor size on the CE-CT or EUS
Time Frame
From baseline to 24 months
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
The incidence of adverse events （such as abdominal pain, hematoma formation, ulcer at the puncture site, acute pancreatitis, pancreatic necrosis, and pancreatic duct stricture）
Time Frame
Within 3 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 NF-pNETs are evaluated by cytology or immunohistochemistry.
Patients who refuse surgery or observation.
Patients who have given their fully informed consent.
Exclusion Criteria:
Patients who are not suitable for EUS-FNI.
Patients who have poor conditions including blood coagulation dysfunction, mental disorders, and 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, MD,Ph.D
Organizational Affiliation
First Affiliated Hospital of Guangxi Medical University
Official's Role
Principal Investigator
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 Nonfunctional Pancreatic Neuroendocrine Tumors
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