Device Assisted Full Thickness Resection Versus Endoscopic Submucosal Dissection for Duodenal Neuroendocrine Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Rate of R0 resection in both the groups
研究概览
简要总结
Introduction :
The incidence of duodenal neuroendocrine tumors (DNETs) is increasing. Endoscopic resection is recommended for the management of small DNETs measuring ≤10 mm. Various endoscopic techniques have been utilized for the resection of DNETs including endoscopic mucosal resection (EMR), band ligation assisted EMR, endoscopic submucosal dissection (ESD). However, the published studies report a high rate of histologically incomplete resection even with ESD. More recently, device assisted endoscopic full thickness resection (EFTR) has emerged as a safe and effective resection modality in cases with upper and lower gastrointestinal (GI) mucosal as well as submucosal lesions. There is limited data on the outcomes of EFTR in cases with DNETs.
In this study, we aim to compare the rate of histologically complete resection (R0) with ESD and EFTR in cases with DNETs.
详细描述
Primary objective:
Rate of R0 resection in both the groups
Secondary outcomes:
- Technical success: defined as en-bloc resection of the lesion without any residual lesion endoscopically
- Procedure duration
- Adverse Events
Inclusion criteria:
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years) with biopsy proven duodenal neuroendocrine tumors (DNETs)
- •Size of the lesion <15 mm
- •Absence of local and distant metastases (EUS and DOTANOC scan)
- •Willing to provide informed consent
排除标准
- •Large lesions >15 mm
- •Invasion of muscularis layer and beyond on imaging (EUS)
- •Scarring or deformity in duodenum
- •Active duodenal ulcer
- •History of prior resection
- •Coagulopathy
结局指标
主要结局
Rate of R0 resection in both the groups
时间窗: 7 days
Endoscopically and pathologically complete resection
次要结局
- Procedure duration(7 days)
- Adverse Events(7 days)
- Technical success: defined as en-bloc resection of the lesion without any residual lesion endoscopically(7 days)
研究者
Mohan Ramchandani
STUDY DIRECTOR
Asian Institute of Gastroenterology, India