EUS-FNI for Nonfunctional Pancreatic Neuroendocrine Tumors

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 85 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05566093
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Guangxi Medical University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Shanyu Qin, MD,Ph.D
Principal Investigator Affiliation	First Affiliated Hospital of Guangxi Medical University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Nonfunctional Pancreatic Neuroendocrine Tumor, Pancreatic Neuroendocrine Tumor, Endoscopic Ultrasound

Additional Details

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.

Arms & Interventions

Arms

Experimental: Nonfunctional pancreatic neuroendocrine tumors

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

Interventions

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.

Contact a Trial Team

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International Sites

Nanning, Guangxi, China

Status

Recruiting

Address

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021

Site Contact

Shanyu Qin, MD,Ph.D

[email protected]

86-771-5356725

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