NCT07655674尚未招募不适用
Effectiveness and Safety of the Endofaster Surgical Robot System for Precise Dissection of Gastroesophageal Submucosal Tumors: A Single-Center Randomized Controlled Study
The First Affiliated Hospital of Soochow University0 个研究点目标入组 110 人开始时间: 2026年7月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
研究概览
简要总结
In endoscopic treatment for gastric submucosal tumors arising from the muscularis propria, does robot-assisted surgery yield a higher serosa preservation rate, shorter operative time and lower complication rates than conventional endoscopic procedures?
详细描述
For endoscopic treatment of gastric submucosal tumors originating from the muscularis propria, this study aims to explore whether robot-assisted therapy can improve serosa preservation rate, shorten operative time and reduce complications compared with conventional endoscopic surgery.
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
- Double (Participant, Outcomes Assessor)
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
- •Aged 18 to 80 years old;
- •Submucosal tumors originating from the muscularis propria of gastric fundus, highly suspected as gastrointestinal stromal tumor (GIST) confirmed by endoscopic ultrasonography (EUS) and contrast-enhanced computed tomography (CT);
- •Tumor diameter ranging from 1.0 cm to 3.0 cm;
- •No active ulcer or bleeding on the lesion surface before operation;
- •American Society of Anesthesiologists (ASA) physical status class I-III;
- •Voluntarily signed written informed consent.
排除标准
- •Tumor adhesion to serosa with unclear interface shown on EUS;
- •High-risk GIST or distant metastasis indicated by imaging or endoscopy;
- •History of gastric surgery or radiotherapy;
- •High bleeding risk including coagulation disorders and patients unable to discontinue anticoagulant medications;
- •Pregnant or breastfeeding women;
- •Failure to cooperate with follow-up.
研究者
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