Conventional Clipping Versus Punching Closure for Defect Closure After ESD:a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Completely closed
研究概览
简要总结
Endoscopic submucosal dissection (ESD) is an important minimally invasive treatment method for early digestive tract tumors, with a high cure rate, and it is widely used in clinical practice. And wound closure after ESD is a great challenge, which is closely related to postoperative perforation bleeding. Clip closure is one of the most commonly used closure methods. However, when the wound is large or when the wound is located more difficult to operate, conventional closure may lead to delayed perforation, and postoperative clips may be prone to early spontaneous shedding. The authors have recently reported a method that may be able to close larger and difficult wounds because the grooves can better fix the metal clips. The latest study suggests that this approach may be safe and effective, but the study has a small sample size and has no controls. Therefore, high-quality clinical study evidence related to punch closure is required in the strategy of defect closure after ESD, in order to better evaluate the feasibility and safety of this new endoscopic closure method.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patients undergoing gastrointestinal ESD wound closure in the First Affiliated Hospital of Ningbo University from April 20, 2024 to December 31, 2025;
- •Age 18-75 years old;
- •Patients who voluntarily agreed to participate in this study and signed informed consent.
排除标准
- •1. Persons under the age of 18
- •Unwilling or unable to provide informed consent
- •Treatment or radiotherapy for malignant diseases, severe chronic heart or lung diseases, coronary or cerebrovascular events requiring hospitalization within the last 3 months 4.. Severe abdominal pain, bloating, nausea and other abdominal symptoms 5.. Patients with lifelong anticoagulant therapy or severe bleeding disorders, and patients who have recently taken anticoagulant or antiplatelet drugs
- •Pregnant or lactating
- •Patients with aggressive lesions and recurrent or residual tumors
结局指标
主要结局
Completely closed
时间窗: 4 weeks
The wound is completely closed without dehiscence
次要结局
- delayed hemorrhage(2 weeks and 4 weeks)
