NCT02488746终止不适用
Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)
Kliniken Ludwigsburg-Bietigheim gGmbH1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2015年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Rate of cases in which a complete macroscopic en bloc resection of the gastric subepithelial tumor could be achieved
研究概览
简要总结
Prospective observational trial. A full thickness resection of gastric subepithelial tumors is performed after application of full thickness sutures underneath the tumor with the GERDX(TM) device. Hypothesis: This endoscopic method is feasible, effective and safe.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •presence of a subepithelial gastric tumor with signs of potential malignancy in endoscopic ultrasound
- •age 18 years or older
- •participant has given informed consent
排除标准
- •tumor size > 40 mm (endosonographic measurement) or large extramural tumor mass
- •signs of systemic dissemination of tumor
- •current presence of a different neoplastic disease (except after successful curative treatment without continued medication)
- •former surgery or disease of esophagus or stomach that impedes insertion of the suturing device
- •moribund patient
- •limited possibility to give informed consent (e.g. language barrier, psychiatric disease)
- •pregnancy and lactation period
结局指标
主要结局
Rate of cases in which a complete macroscopic en bloc resection of the gastric subepithelial tumor could be achieved
时间窗: intraoperative
次要结局
- Number of participants with needs of surgical therapy or endoscopic re-resection(6 months after resection)
- Rate of cases in which a complete microscopic resection of the gastric subepithelial tumor could be achieved(within one week after resection (as soon as result of pathologic analysis of resected specimen is available))
- Rate of complications (bleeding, perforation)(6 months after resection)
- Duration of hospitalization(within one week after resection)
- Number of participants with local or systemic recidive of tumor(6 months after resection)
研究者
研究点 (1)
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