A Multicenter, Prospective, Randomized Controlled Study on EUS-Guided Precise Disconnection of Varices Versus Endoscopic Gastric Variceal Glue Injection for the Prevention of Gastric Variceal Bleeding.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Gastric variceal bleeding within 1 year.
研究概览
简要总结
The purpose of this clinical trial is to evaluate whether Endoscopic Ultrasound-Guided Selective Variceal Devascularization (EUS-SVD) is effective in preventing the re-bleeding of gastric varices. It will also investigate the safety of EUS-SVD. The main questions it aims to answer are:
Does EUS-SVD lead to a greater reduction in the one-year gastric variceal re-bleeding rate among participants compared to conventional Endoscopic Gastric Variceal Obturation (GVO)?
What medical problems (adverse events) do participants experience when receiving EUS-SVD treatment?
Researchers will compare EUS-SVD with GVO (a currently commonly used first-line treatment method) to see if EUS-SVD can be a superior option for treating gastric varices.
Participants will:
Be randomly assigned to undergo either the EUS-SVD or the GVO procedure.
Receive treatment in the hospital and be hospitalized for observation (approximately 5 days for the EUS-SVD group, 3 days for the GVO group).
Return to the hospital for a follow-up gastroscopy or endoscopic ultrasound examination at 3 months after the procedure.
Receive telephone or outpatient follow-ups at 6 months and 12 months after the procedure to report their health status and any bleeding episodes.
Throughout the study period, record and report any re-bleeding events, need for re-intervention, and other complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Chinese population aged 18-80 years;
- •High-risk gastric varices confirmed by gastroscopy (for primary prevention) or active bleeding due to gastric varices or a history of acute gastric variceal bleeding within the past 1 month (for secondary prevention);
- •Subjects who prefer endoscopic treatment and voluntarily sign the informed consent form.
排除标准
- •(1) Subjects with a history of secondary preventive treatment for gastric varices or shunt surgery; (2) Subjects complicated with hepatorenal syndrome, hepatic encephalopathy grade III/IV, or severe jaundice (serum bilirubin >10 mg/dl); (3) Subjects complicated with multiple organ failure or advanced malignant tumors; (4) Subjects who are pregnant, in gestation, or lactating; (5) Subjects suspected of having splenic vein or portal vein thrombosis; (6) Subjects with coagulation dysfunction, platelet count <50,000/mL or INR ≥2; (7) Subjects with esophageal stenosis or a history of esophageal or gastric surgery; (8) Subjects deemed unsuitable for this study by physician evaluation.
研究组 & 干预措施
EUS-Guided Precise Disconnection of Varices or the Prevention of Gastric Variceal Bleeding.
干预措施: EUS-Guided Precise Disconnection of Varices (Procedure)
Endoscopic Gastric Variceal Glue Injection for the Prevention of Gastric Variceal Bleeding.
干预措施: EUS-Guided Precise Disconnection of Varices (Procedure)
结局指标
主要结局
Gastric variceal bleeding within 1 year.
时间窗: 1 year
次要结局
未报告次要终点