NCT03705078已完成不适用
A Multicenter Randomized Clinical Trial Comparing Two Treatment Strategies to Prevent Rebleeding From Gastric Varices: "Early TIPS" Versus Glue Obliteration
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 20
- 主要终点
- death
研究概览
简要总结
The primary objective of the study is to demonstrate the superiority of an "early tips" strategy over standard treatment by glue obliteration (G0) in preventing bleeding recurrence or death at one year after a non GOV1 gastric variceal bleeding in cirrhotic patients initially treated by GO.
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
- 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
- •Cirrhotic patients: the diagnosis of liver cirrhosis will be based on previous needle liver biopsy or on the combination of clinical, biochemical, and radiological findings. If biopsy findings are unavailable and in case of non-complicated cirrhosis, non-invasive markers will be used.
- •Variceal bleeding at endoscopy from gastroesophageal gastric varices type 2 or isolated gastric varices type 1 or 2 (Sarin classification) according to the following criteria: endoscopic signs of an active spurting or oozing from gastric varices (GV); adherent blood clots, white nipple signs, or erosions on the GV and absence of other bleeding sources.
- •Hemodynamically stable patient (Mean arterial pressure above 65 mmHg) without clinical significant rebleeding (Baveno criteria) within 12 hours after the initial endoscopy with glue obliteration.
- •Written informed consent obtained.
排除标准
- •Pregnant woman or breastfeeding.
- •Minor and patients older than 75 years.
- •Non cirrhotic portal hypertension.
- •Hepatocellular carcinoma outside the Milan criteria or other cancer at a palliative stage.
- •Child Pugh score >
- •History of severe or refractory hepatic encephalopathy unrelated to gastrointestinal bleeding.
- •Congestive heart failure.
- •History or presence of pulmonary hypertension.
- •Patients with other indication for TIPS.
- •Uncontrolled gastric variceal bleeding.
- •Portal vein cavernoma.
- •Patient who have previously received a TIPS procedure.
- •Failure to receive clear information in patients without an identified trusted person.
- •Refusal of the participation agreement by signing the information form and consent as defined.
- •Exclusion period from another biomedical study.
结局指标
主要结局
death
时间窗: 12 months
Incidence of clinically significant rebleeding (upper gastrointestinal bleeding whatever its origin)
时间窗: 12 months
Defined by Baveno VI consens group as a recurrent melena or hematemesis resulting in any of the following: * Hospital admission * Blood transfusion * 3 g/dL drop in hemoglobin
次要结局
- Frequency of glue obliteration complications(12 months)
- Incidence of rebleeding(12 months)
- Frequency of TIPS complications(12 months)
- All-cause mortality and liver-related mortality(12 months)
- MELD score (Model for End Stage Liver Disease) in TIPS group(6 months)
- MELD score (Model for End Stage Liver Disease) in glue obliteration group(6 months)
- Cumulative number of packed red blood cells(12 months)
- Incidence of complications of cirrhosis (infections, ascites, hepatic encephalopathy, hepatorenal syndrome) during follow-up(12 months)
- Number of days of hospitalization(12 months)
研究者
研究点 (20)
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