Safety and Efficacy of Underwater Endoscopic Mucosal Resection for Type I Gastric Neuroendocrine Tumors Measuring 5-9 mm: A Prospective Single-Centre Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- • To determine the histologic R0 resection rate of UEMR for type I gastric NETs measuring 5-9 mm.
研究概览
简要总结
Study objectives:
Primary objective:
1.To determine the histologic R0 resection rate of UEMR for type I gastric NETs measuring 5-9 mm.
Secondary objectives:
To evaluate:
- En bloc resection rate
- Immediate and delayed adverse events
- Procedure time
- Histologic quality of resection (deep and lateral margins)
- Residual disease at resection scar on surveillance endoscopy oMetachronous gastric NETs during follow-up
详细描述
Study design This is a prospective, single-centre, single-arm cohort study evaluating UEMR for type I gastric NETs. Outcomes will be assessed at the lesion level, with statistical methods accounting for clustering of multiple lesions within individual patients.
Study population Inclusion criteria Patient-level
- Age ≥18 years
- Fit for endoscopic therapy and sedation
- Written informed consent Lesion-level
3.Endoscopically visible gastric neuroendocrine tumor 4.Size 5-9 mm (endoscopic estimation) 5.Clinical and/or histologic features consistent with type I gastric NET 6.No endoscopic features suggestive of deep invasion 7.Technically amenable to snare resection Exclusion criteria
Lesion-level
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient-level
- •Age ≥18 years
- •Fit for endoscopic therapy and sedation
- •Written informed consent
排除标准
- •Lesion-level
- •Endoscopically visible gastric neuroendocrine tumor
- •Size 5-9 mm (endoscopic estimation)
- •Clinical and/or histologic features consistent with type I gastric NET
- •No endoscopic features suggestive of deep invasion
- •Technically amenable to snare resection
结局指标
主要结局
• To determine the histologic R0 resection rate of UEMR for type I gastric NETs measuring 5-9 mm.
时间窗: 3 months
No recurrence after 3 months of procedure
次要结局
- Immediate and delayed adverse events(24 hours)
- Procedure time(30 minutes)
- Histologic quality of resection (deep and lateral margins)(5 days)
研究者
Mohan Ramchandani
Study Chair
Asian Institute of Gastroenterology, India