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Trial Title:
EUS-FNI for Nonfunctional Pancreatic Neuroendocrine Tumors
NCT ID:
NCT05566093
Condition:
Nonfunctional Pancreatic Neuroendocrine Tumor
Pancreatic Neuroendocrine Tumor
Endoscopic Ultrasound
Conditions: Official terms:
Neoplasms
Neuroendocrine Tumors
Adenoma, Islet Cell
Pancreatic Neoplasms
Ethanol
Polidocanol
Conditions: Keywords:
Nonfunctional Pancreatic Neuroendocrine Tumor
Endoscopic ultrasonography-guided fine-needle injection
Ablation
Endoscopic ultrasonography
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
EUS-guided ethanol ablation
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.
Arm group label:
Nonfunctional pancreatic neuroendocrine tumors
Intervention type:
Procedure
Intervention name:
EUS-guided lauromacrogol ablation
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.
Arm group label:
Nonfunctional pancreatic neuroendocrine tumors
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with NF-pNETs are evaluated by cytology or immunohistochemistry.
2. Patients who refuse surgery or observation.
3. Patients who have given their fully informed consent.
Exclusion Criteria:
1. Patients who are not suitable for EUS-FNI.
2. Patients who have poor conditions including blood coagulation dysfunction, mental
disorders, and mild or severe cardiorespiratory.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Guangxi Medical University
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Contact:
Last name:
Shanyu Qin, MD,Ph.D
Phone:
86-771-5356725
Email:
qsy0511@163.com
Investigator:
Last name:
Shanyu Qin, MD,Ph.D
Email:
Principal Investigator
Start date:
September 28, 2018
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Guangxi Medical University
Agency class:
Other
Source:
Guangxi Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05566093
