EUS-FNI for Nonfunctional Pancreatic Neuroendocrine Tumors

Sponsor

Guangxi Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05566093

Collaborator

(none)

Enrollment

Location

Arm

87.1

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Nonfunctional Pancreatic Neuroendocrine Tumor Pancreatic Neuroendocrine Tumor Endoscopic Ultrasound	Procedure: EUS-guided ethanol ablation Procedure: EUS-guided lauromacrogol ablation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 28, 2018

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nonfunctional pancreatic neuroendocrine tumors The patients with NF-pNETs will undergo EUS-guided ethanol or lauromacrogol ablation	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. Procedure: 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.

Arm

Intervention/Treatment

Experimental: Nonfunctional pancreatic neuroendocrine tumors

The patients with NF-pNETs will undergo EUS-guided ethanol or lauromacrogol ablation

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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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）

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.