跳至主要内容
临床试验/NCT07230665
NCT07230665Enrolling By Invitation不适用

Outcome of Patients With Malignant Gastric Outlet Obstruction Undergoing Endoscopic Ultrasound-guided Gastroenterostomy or Enteral Metal Stenting: a Prospective Cohort Study

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年8月14日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
200
试验地点
1
主要终点
Reintervention rate

研究概览

简要总结

Gastric outlet obstruction (GOO) refers to a mechanical blockage of the distal stomach or duodenum that prevents normal passage of food and liquids. According to literature, 50-80% of GOO cases are caused by malignant tumors compressing or directly invading the gastrointestinal tract. Among patients with pancreatic cancer, 15-20% develop GOO [1,2]. GOO is also considered a poor prognostic factor in malignancy, with a median survival time of only 3-6 months [3].

Traditionally, management options for GOO include surgical gastrojejunostomy and endoscopic enteral metal stent (ES) placement. Endoscopic approaches are less invasive, allow earlier oral intake, and reduce hospital stay [4-6]. Considering that most patients with malignant GOO are debilitated, a less invasive option is often preferable.

In recent years, endoscopic ultrasound-guided gastroenterostomy (EUS-GE) has emerged as an alternative. A recent systematic review and meta-analysis comparing ES and EUS-GE found similar technical and clinical success rates, but significantly lower re-intervention rates in the EUS-GE group [7]. However, most existing studies are retrospective and lack systematic, prospective follow-up data comparing the two approaches remain lacking.

This study aims to prospectively evaluate and compare the short- and long-term outcomes-including stent function, oral intake, nutritional status, and quality of life-of patients with malignant GOO undergoing either EUS-GE or conventional enteral stenting.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •Consecutive patients aged 18 years or older who underwent ES or EUS-GE for unresectable mGOO were enrolled

排除标准

  • •Prior enteral stent placement
  • •Multi-level bowel obstruction,
  • •Linitis plastica of the stomach
  • •A life expectancy of less than one mont
  • •Uncorrected coagulopathy
  • •Pregnancy
  • •Inability to provide informed consent

结局指标

主要结局

Reintervention rate

时间窗: one year

Defined as the need for additional endoscopic treatment due to recurrent GOO symptoms

次要结局

  • Technical success(one year)
  • Clinical success(one year)
  • Gastric outlet obstruction score (GOOS) changes(one year)
  • Adverse events (AEs)(one year)
  • Survival(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

National Taiwan University Clinical Trial Center

Principal Investigator

National Taiwan University Hospital

研究点 (1)

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