Endoscopic Ultrasound, Nonfunctional Pancreatic Neuroendocrine Tumor, Pancreatic Neuroendocrine Tumor
Conditions
Keywords
Nonfunctional Pancreatic Neuroendocrine Tumor, Endoscopic ultrasonography-guided fine-needle injection, Ablation, Endoscopic ultrasonography
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.
Interventions
PROCEDUREEUS-guided ethanol ablation
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.
PROCEDUREEUS-guided lauromacrogol ablation
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.
Sponsors
Guangxi Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of complete ablation | At 24 months after treatment | The rate of complete ablation on the CE-CT or CE-EUS |
| The Chang The change of tumor size | From baseline to 24 months | The change of tumor size on the CE-CT or EUS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Within 3 month after treatment | The incidence of adverse events （such as abdominal pain, hematoma formation, ulcer at the puncture site, acute pancreatitis, pancreatic necrosis, and pancreatic duct stricture） |
Countries
China
Contacts
Primary ContactShanyu Qin, MD,Ph.D
Backup ContactHaixing Jiang, MD,Ph.D
Outcome results
None listed