EUS-FNI for Nonfunctional Pancreatic Neuroendocrine Tumors

Pancreatic Neuroendocrine Tumor Clinical Trial

Official title:

Endoscopic Ultrasound-guided Fine-needle Injection for Nonfunctional Pancreatic Neuroendocrine Tumors: a Prospective Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05566093
• Other study ID #: 2022-K039-01
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2022
• Source: Guangxi Medical University
• Contact: Shanyu Qin, MD,Ph.D
• Phone: 86-771-5353725
• Email: qsy0511[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study aims to access the feasibility, safety, and efficacy of EUS-FNI for nonfunctional pNETs

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endoscopic Ultrasound
• Neoplasms
• Neuroendocrine Tumors
• Nonfunctional Pancreatic Neuroendocrine Tumor
• Pancreatic Neoplasms
• Pancreatic Neuroendocrine Tumor

Intervention

Procedure:
• EUS-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.
• EUS-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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of complete ablation	The rate of complete ablation on the CE-CT or CE-EUS	At 24 months after treatment
Primary	The Chang The change of tumor size	The change of tumor size on the CE-CT or EUS	From baseline to 24 months
Secondary	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)	Within 3 month after treatment