A Single-center Exploratory Clinical Study on the Use of Removable Titanium Clips for the Treatment of Acute Variceal Hemorrhage from the Gastric Fundus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Rebleeding rate within 5 days after treatment
研究概览
简要总结
Removable Titanium Clip Treatment for Acute Variceal Hemorrhage from the Gastric Fundus
详细描述
During the procedure, a removable titanium clip was used to block the bleeding vessels, enabling rapid hemostasis. Five days later, secondary preventive measures such as ECI or TIPS were performed. The titanium clip was removed during or after the procedure, avoiding its retention in the body, which could interfere with subsequent MRI examinations and related treatments. In situations where emergency ECI or other treatments are not feasible, this method can serve as a 'temporary bridge' for the treatment of acute gastric fundal variceal hemorrhage, potentially saving the patient's life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •The patient and their family agree to and sign the relevant informed consent form.
- •Diagnosed with cirrhosis based on clinical manifestations, laboratory tests, imaging findings, or pathological examinations.
- •History of symptoms related to variceal upper gastrointestinal bleeding, such as hematemesis, melena, or rectal bleeding.
- •Patients confirmed by endoscopy to have bleeding from ruptured gastric varices.
- •Patients who are hemodynamically stable before or after initial fluid resuscitation.
- •Aged 18 to 75 years.
排除标准
- •Those with concomitant bleeding from ruptured esophageal varices.
- •A history of gastrointestinal-related surgical procedures.
- •Individuals with altered consciousness who are difficult to treat.
- •Those with concomitant malignant tumors.
- •Individuals with serious diseases involving the heart, brain, lungs, or kidneys.
- •Pregnant and breastfeeding women.
- •Those with contraindications to relevant treatments.
研究组 & 干预措施
a removable titanium clip
干预措施: a removable titanium clip (Device)
结局指标
主要结局
Rebleeding rate within 5 days after treatment
时间窗: within 5 days after treatment
Signs of rebleeding: A clinically significant event of active bleeding after hemostasis (hematemesis, melena, or rectal bleeding; a decrease in systolic blood pressure of \>20 mmHg or an increase in heart rate of \>20 beats/min; a drop in hemoglobin of \>30 g/L without blood transfusion). (1) Early rebleeding: Occurs within 120 hours to 6 weeks after hemostasis. (2) Delayed rebleeding: Occurs more than 6 weeks after hemostasis. Non-EVB patients are excluded.
次要结局
未报告次要终点
研究者
Shupei Li
student
Jinling Hospital, China