NCT02784470Unknown3 期
Study of Gastroduodenal Metallic Stent vs Gastrojejunostomy
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Gastric Outlet Obstruction Scoring System (GOOSS) score
研究概览
简要总结
Selection of the optimal treatment for gastric outlet obstruction in patients with radically unresectable gastric cancer remains controversial because previous studies comparing the two procedures had a small sample size as well as they included various etiologies such as gastrointestinal (GI) cancer, duodenal cancer and pancreaticobiliary cancer in selecting the patient population. Therefore, to establish the standard of care for patients with radically unresectable gastric cancer with gastric outlet obstruction, a larger prospective, randomized, controlled clinical trial using a single type of stent is warranted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥19 to 80 years
- •ECOG performance status 0-3
- •Life expectancy >3 months
- •Patients with malignant gastric outlet obstruction (distal part of stomach, pyloric ring or duodenal bulb obstruction) caused by gastric cancer
- •Patients who are not eligible for radical operation due to local progression of gastric cancer, distant metastasis or his/her general condition.
- •Patients with GOOSS score 0-2
- •Patients with symptoms consistent with gastric outlet obstruction including persistent nausea and vomiting
- •Patients with findings consistent with malignant gastric outlet obstruction on imaging studies including upper GI endoscopy, upper GIseries or abdominal computed tomography (CT)
- •Patients who are eligible to undergo both gastroduodenal stent placement and gastrojejunostomy (eligibility will be determined by agreement by at least one gastroenterological surgeon and at least one radiologist)
- •Patients who have been provided with an explanation of the procedures of the clinical trial, voluntarily decided participation and signed the informed consent form
排除标准
- •Pregnant or lactating women
- •Women of childbearing potential with positive pregnancy test at baseline. Post-menopausal women should have at least 12 months of amenorrhea to be considered not of childbearing potential.
- •Patients who have previously undergone balloon dilatation or stent placement for malignant gastric outlet obstruction
- •Patients with past history of palliative bypass surgery or gastrectomy
- •Patients with peritoneal metastasis or multiple intestinal obstruction caused by other cause on imaging scan including abdominal CT or small bowel series
- •Patients who have been treated for intestinal adhesion caused by previous abdominal surgery
- •Patients who are not eligible for general anesthesia due to poor general condition
- •Patients with clinical evidence of intestinal perforation or peritonitis
- •Patients who are determined to be not eligible for stent placement or gastrojejunostomy due to other cause
结局指标
主要结局
Gastric Outlet Obstruction Scoring System (GOOSS) score
时间窗: Up to 2 years
次要结局
未报告次要终点
研究者
Moon-Won Yoo
Professor
Asan Medical Center
研究点 (2)
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