Efficacy and Safety of Contrast Endoscopic Ultrasound-Guided Tissue Glue/Coil Devascularization vs. Balloon-Occluded Retrograde Transvenous Obliteration for Preventing Recurrent Gastric Variceal Bleeding: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- One-year all-cause rebleeding rate
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of EUS-guided tissue glue/coil injection and BRTO in preventing rebleeding of gastric varices (GVs) in patients with portal hypertension and GVs (including those with esophageal varices, ascites, or hepatic encephalopathy). The main questions it aims to answer are:
Is the 1-year all-cause rebleeding rate of EUS-guided tissue glue/coil injection for GVs non-inferior to that of the BRTO group? Does EUS-guided tissue glue/coil injection differ from BRTO in the incidence of decompensated portal hypertension events (variceal bleeding, overt hepatic encephalopathy, ascites) and survival rate post-treatment?
Researchers will compare patients randomized 1:1 to the EUS-guided tissue glue/coil injection arm vs. the BRTO arm to see if there are differences in rebleeding rates and complications.
Participants will:
Receive EUS-guided tissue glue/coil injection or BRTO. Take carvedilol long-term (if no contraindications) to reduce portal pressure. Undergo follow-up assessments at 1, 3, 6, and 12 months ±7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Aged between 18 and 75 years old;
- •Liver cirrhosis (diagnosed by imaging, laboratory tests, clinical symptoms, or liver biopsy);
- •Experienced bleeding of gastroesophageal varices (GVs) (GOV1, GOV2, or IGV1) within 5 days to 1 year (bleeding lesions observed under endoscopy originating from GVs, or no other bleeding lesions except GVs were found);
- •Presence of spontaneous portosystemic shunts that are technically feasible for BRTO; ⑤ Willing to participate in this clinical study, comply with the study requirements, and sign the informed consent form.
排除标准
- •Previously received vascular interventional therapy for preventing rebleeding of GVs;
- •Eligible for variceal ligation treatment of GOV1;
- •Non-cirrhotic portal hypertension (including regional portal hypertension);
- •Previously underwent surgical and interventional shunt procedures;
- •Presence of contraindications to endoscopic or interventional treatment; ⑥ Extensive portal vein thrombosis, cavernous transformation of the portal vein;
- •⑦ Massive ascites;
- •⑧ Concurrent advanced liver cancer or other malignant tumors with a predicted lifespan of less than 3 months;
- •⑨ Concurrent severe diseases of other organs such as the heart, lungs, and kidneys;
- •⑩ Pregnant or lactating women.
研究组 & 干预措施
EUS-guided tissue glue/coil injection arm
Under linear array endoscopic ultrasound (EUS), puncture GVs with a 19G/22G needle, deploy coils, and inject 1-2ml tissue glue until blood flow in GVs disappears (or inject glue directly if coils are unsuitable). Treat moderate-to-severe esophageal varices (EVs) with band ligation during or after the procedure.
干预措施: EUS-guided tissue glue/coil injection (Procedure)
BRTO arm
Establish vascular access via the femoral or internal jugular vein, occlude gastrorenal shunts with a balloon catheter, and inject sclerosant foam. Treat moderate-to-severe EVs with band ligation within 5 days post-procedure.
干预措施: BRTO (Procedure)
结局指标
主要结局
One-year all-cause rebleeding rate
时间窗: one year
The rate of upper gastrointestinal bleeding occurring within one year after the operation, regardless of the cause
次要结局
未报告次要终点
研究者
Yang Jinlin
Professor
West China Hospital