NCT03247231终止不适用
Effectiveness and Safety of the Endoscopic Band Ligation Without Resection of ≤15-mm Subepithelial Tumours of the Digestive Tract: a Multicenter Prospective Study
Joan B Gornals7 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2017年3月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 157
- 试验地点
- 7
- 主要终点
- Removal of the subepithelial tumour (initial clinical success).
研究概览
简要总结
To analyse the effectiveness and safety of endoscopic band ligation without resection in small gastrointestinal subepithelial tumours.
详细描述
Multicenter prospective study analysing the effectiveness and safety of endoscopic band ligation without resection in small (≤15-mm) gastrointestinal subepithelial tumours.
This endoscopic technique will be complemented with a SINK (single-incision needle-knife) biopsy for ensuring the pathological diagnosis of the treated subepithelial tumour.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Removal of the subepithelial tumour (initial clinical success).
时间窗: 4-6 weeks
Complete removal and disappearance of the subepithelial tumour at 4-6 weeks by endoscopic ultrasonography control.
次要结局
- Number of participants with treatment-related adverse events as assessed by American Society of Gastrointestinal Endoscopy (ASGE) guideline.(1 year)
- SINK biopsy efectiveness.(4-6 weeks)
- Removal of the subepithelial tumour (global clinical success).(1 year)
- Technical success.(First day)
- Long-term recurrence.(5 years)
研究者
Joan B Gornals
Principal investigator
Hospital Universitari de Bellvitge
研究点 (7)
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