EUS-FNI for Nonfunctional Pancreatic Neuroendocrine Tumors

Not Applicable

Recruiting

• Conditions: Pancreatic Neuroendocrine Tumor; Endoscopic Ultrasound; Nonfunctional Pancreatic Neuroendocrine Tumor
• Interventions: Procedure: EUS-guided ethanol ablation; Procedure: EUS-guided lauromacrogol ablation

• Registration Number: NCT05566093
• Lead Sponsor: Guangxi Medical University

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.

Study Timeline

• Study Start: 2018-09-28
• Status Verified: 2022-09
• Study First Submitted: 2022-09-25
• Study First Submitted QC: 2022-09-30
• Last Update Submitted: 2022-09-30
• Study First Posted: 2022-10-04
• Last Update Posted: 2022-10-04
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nonfunctional pancreatic neuroendocrine tumors	EUS-guided ethanol ablation	The patients with NF-pNETs will undergo EUS-guided ethanol or lauromacrogol ablation
Nonfunctional pancreatic neuroendocrine tumors	EUS-guided lauromacrogol ablation	The patients with NF-pNETs will undergo EUS-guided ethanol or lauromacrogol ablation

Primary Outcome Measures

Name	Time	Method
The Chang The change of tumor size	From baseline to 24 months	The change of tumor size on the CE-CT or EUS
The rate of complete ablation	At 24 months after treatment	The rate of complete ablation on the CE-CT or CE-EUS

Secondary Outcome Measures

Name	Time	Method
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）

Trial Locations

Locations (1)

First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China