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临床试验/NCT02121366
NCT02121366Unknown不适用

Endoscopic Ultrasound (EUS)-Guided Ethanol Ablation of an Insulinoma - A Multi-center Prospective Cohort Study

Guangxi Medical University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Efficacy of EUS-guided ethanol ablation

研究概览

简要总结

The present study aims to evaluate the feasibility, safety and efficacy of EUS-guided ethanol ablation of an insulinoma.

详细描述

As the major insulinomas are functioning islet cell tumors, surgical resection is currently first-line therapy for or treatment of insulinomas. However, the surgical resection of pancreatic neoplasm is conditional for specific patients and may be associated with substantial life-threatening complications. Several studies declared that endoscopic ultrasound (EUS)-guided lavage may offer an alternative to surgical resection of insulinomas. Nevertheless, their sample sizes were small and conclusions were built based on short-term outcomes. In addition, the amount of ethanol administrated for different types of insulinomas were inconsistent among those studies.

The present study aims to evaluate the safety, feasibility and efficacy of EUS-guided ethanol ablation therapy of insulinomas. We will use cytopathology and immunohistochemistry in combination with EUS-FNA for diagnosis of insulinoma. After EUS-guided ethanol ablation therapy, the safety and efficacy will be assessed at the baseline and different time points during follow-up by physicians blinded to the treatment or control status.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults: at least 18 years.
  • Patients with insulinomas which are evaluated by histopathology .
  • patients who have signed a written consent form.

排除标准

  • Patients whose condition is not suitable for the endoscopic procedure.
  • Patients who have blood coagulation dysfunction.
  • Patients who have mental disorders.
  • Patients who have mild or severe cardiorespiratory insufficiency.
  • Patients who have hypertension and could not be controlled to safe level.
  • Pregnant and lactating women.
  • Patients whose conditions are not suitable for the present study.

结局指标

主要结局

Efficacy of EUS-guided ethanol ablation

时间窗: 1 to 12 month

Volumes of insulinomas before and after treatment, which are measured by cross-sectional imaging test (CT or MRS).

Safety of EUS-guided ethanol ablation

时间窗: 1 to 12 month

Number of subjects with post-procedure adverse events

次要结局

  • Technical feasibility(during the procedure of treatment)

研究者

发起方
Guangxi Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shanyu Qin

First Affiliated Hospital of Guangxi Medical University

Guangxi Medical University

研究点 (1)

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